Ginsenoside composition

Abstract

The present invention relates to the use of American ginseng (Panax quinquefolius) to prevent and / or reduce fatigue in a subject. The present invention also relates to the use of a composition comprising ginsenosides and an extract of American ginseng (Panax quinquefolius) for increasing attention / alertness in a subject. The present invention also relates to the use of American ginseng (Panax quinquefolius) to increase self-confidence in a subject.

Description

Technical Field

[0003] , , , Background of the Invention , , , ,

[0004]

[0001] Field of the present invention The present invention relates to the use of American ginseng (Panax quinquefolius) for preventing and / or reducing fatigue in a subject. The present invention also relates to the use of American ginseng (Panax quinquefolius) for increasing attention / agility in a subject. The present invention also relates to the use of American ginseng (Panax quinquefolius) for increasing confidence in a subject.

Background Art

[0002] Background of the Invention A list or discussion of apparent prior publications in this specification is not necessarily to be selected as an admission that such documents are part of the state of the art or common general knowledge. The term "ginseng" is generally used to refer to species of the genus Panax of the Araliaceae family. Extracts of Asian ginseng (Panax ginseng) have been used in traditional Chinese medicine for thousands of years.

[0003] American ginseng (Panax quinquefolius) has a distinct ginsenoside profile form of Panax ginseng and has recognized cognitive enhancing properties.

[0004] The study evaluated the latent learning and memory benefits of a standardized, dedicated North American ginseng (Panax quinquefolius) extract containing HT1001, Rb1, Rb2, Rc, Rd, Re, and Rg1 (13-20% of total ginsenosides) in healthy volunteers. Neuropsychological assessments were performed using the Clinical Memory Scale (CMS), which has two parallel forms for baseline and post-treatment assessments. Young adult (YAS, n=10) and middle-aged (MAS, n=10) participants completed the CMS at baseline and again after 14 days of daily exposure to 200 mg of HT1001. The CMS Memory Quotient (MQ) showed a significant primary effect of time with higher CMS-MQ on the second assessment compared to the first, and of age groups with YAS performing better than MAS. There was no interaction between time and age groups. The second analysis pointed to the benefits for both groups in free memory of word lists, cue memory of word pairs, and figure recognition, as well as the benefit in YAS rather than MAS in free memory of images. Taken together, the results suggest that memory was significantly improved by open-label HT1001, as measured by CMS-MQ. A limitation of this study is the lack of a placebo control, and therefore the effect of this extract lacked empirical evidence. [Overview of the Initiative]

[0005] The applicant hereby has found, in a surprising manner, that an extract of American ginseng (Panax quinquefolius) has an unexpected effect in reducing fatigue.

[0006] Until now, the beneficial effects of ginseng on fatigue, agility, and confidence were not known. This invention provides extracts and methods of using ginseng to reduce fatigue in subjects, including a reduction in feelings of tiredness, drowsiness, etc. The inventors have found that administering ginseng improves mood and agility.

[0007] In a first aspect, the present invention provides compositions comprising ginsenosides (or compositions of the present invention) for use in treating, reducing, defending against, and / or improving fatigue, improving or increasing attention / agility, and / or improving or increasing self-confidence. Therefore, in a second aspect, the present invention provides Panax quinquefolius extract for use in the following: (a) To treat, reduce, protect against, and / or improve fatigue; (b) To improve or increase attention / agility; and / or (c) To improve or increase self-confidence.

[0008] In a second aspect, the present invention provides for the use of the composition of the present invention or the extract of the present invention (Panax quinquefolius extract) in a subject for: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving or increasing attention / agility; and / or (c) improving or increasing self-confidence.

[0009] In a third aspect, the present invention includes administering an effective amount of a composition containing a ginsenoside or an extract of Panax quinquefolius to a subject in need thereof. (a) To treat, reduce, protect against, and / or improve fatigue; (b) To improve or increase attention / agility and / or (c) To improve or increase self-confidence, Provide a method.

[0010] Details, examples, and options provided in connection with any one or more of the expressed aspects of the Invention are further described herein and apply equally to all aspects of the Invention. Any combination of the embodiments, examples, and options described herein below, in all possible variations thereof, is encompassed by the Invention unless otherwise specifically noted herein or explicitly rejected by the context.

[0011] Detailed description of the invention As asserted, it should be understood that the above general statements and the following detailed statements are illustrative and descriptive only, and not limiting in nature. In this specification, unless specifically stated otherwise, the use of the singular includes the plural. When used in this specification, unless specifically stated otherwise, the use of “or” means “and / or.” Furthermore, the use of the term “including,” as well as other forms such as “includes,” “included,” etc., is not limiting.

[0012] The section headings used herein are for constituent purposes only and should not be construed as limiting the constituent elements described. All documents or parts of documents cited herein, including but not limited to patents, patent applications, articles, books, etc., are expressly incorporated herein by reference, both for the parts of documents discussed herein and in whole. This invention is based on the remarkable discovery that long-term consumption of Panax quinquefolius (American ginseng) can reverse fatigue and improve confidence, attention, and agility.

[0013] Composition containing ginsenoside According to the present invention, a composition comprising a ginsenoside is provided, which may hereafter be referred to herein as "the first composition of the present invention." Ginsenosides are saponins and are the main pharmacologically active components of the Panax plant genus.

[0014] More than 40 structurally branched ginsenosides have been isolated, identified from the roots of the genus Panax, described, for example, in the publications of Razgonova et al., and are included here by reference. (Razgonova, MP, et al. . (2019). Molecular medicine reports, 19(4), 2975-2998.) Ginsenosides are divided into three groups based on their chemical structure: protopanaxadiols (PD) including Rb1, Rb2, Rb3, Rc, etc.; protopanaxatriols (PT) including Re, Rf, Rg1, Rg2, RhI; and the oleanolic acid group (e.g., Ro) (Qi, LW, Wang, CZ, & Yuan, CS (2011). Isolation and analysis of ginseng: advances and challenges. Natural product reports, 28(3), 467-495).

[0015] As used herein, the term “ginsenosides” or “ginsenoside(s)” may refer to any one of the more than 40 ginsenosides isolated and purified from the roots of the genus Panax (Panax ginseng, Panax notoginseng, and / or Panax quinquefolius), which have been widely documented in the literature, such as Rb1, Rb2, Rb3, Rc, Re, Rf, Rg1, Rg2, Rhl, Ro, etc. It may refer to a single specific ginsenoside (i.e., more than 99.9% Rb1) or a mixture of two or more of the ginsenosides (Rb1 and Rb2, etc.).

[0016] Typically, the ginsenoside(s) may be obtained from any natural source containing ginsenosides of the kind described herein, using the processes described herein, for example from the genus Panax, specifically Panax ginseng (or Korean ginseng i.e. KG), Panax notoginseng (or Southern Chinese ginseng i.e. CHG), and / or Panax quinquefolius (American ginseng i.e. AG). In a preferred embodiment, the ginsenoside is extracted from Panax quinquefolius.

[0017] The composition containing ginsenoside (or the first composition of the present invention) may be obtained directly from the ground roots of Panax ginseng, Panax notoginseng, and / or Panax quinquefolius.

[0018] The method for preparing the composition containing ginsenoside (or the first composition of the present invention) may be an extraction method using various suitable solvents for extracting the ginsenoside from a natural source containing ginsenosides such as Panax ginseng, Panax notoginseng, and / or Panax quinquefolius.

[0019] In a preferred embodiment, the ginsenoside of the first composition of the present invention may be isolated from the ginsenosides contained in a natural source (such as the roots of American ginseng, especially AG) using separation techniques that can be selected for the required extract, which may be determined by those skilled in the art.

[0020] Typically, the ginsenoside of the first composition of the present invention may be obtained by generally the extraction and isolation processes described herein, or routine modifications thereof.

[0021] For example, the process for isolation and extraction of the ginsenoside contained in the composition of the present invention may include (or consist essentially of / consist of) the following steps: (i) Extraction of a natural source containing ginsenosides, such as the roots (which may be ground) of Panax ginseng, Panax notoginseng, and / or Panax quinquefolius, with a suitable solvent; (ii) Evaporation of the solvent; and, if required (iii) Purification of the ginsenosides (e.g., by chromatography).

[0022] Typically, the roots of Panax ginseng, Panax notoginseng, and / or Panax quinquefolius are ground into granules having a particle size ranging from about 0.1 mm to about 30 mm, and the solvent increases the surface area in contact and the extraction efficiency.

[0023] Special solvents that may be used in the extraction process include alcohols (such as methanol), and alcohol / water mixtures (such as a mixture of methanol and water). For example, the extraction solvent can be water, a water - alcohol mixture (from about 1% to about 99% alcohol in water, such as from about 30% to about 75% alcohol in water, or from about 30% to about 50% alcohol in water, about 35% to about 40% alcohol in water, etc.), or an alcohol. Special alcohols that may be mentioned include ethanol (EtOH) and methanol (MeOH).

[0024] In a particular embodiment, the extraction solvent may be an ethanol - water mixture, such as from about 30% to about 90% ethanol in water, or from about 30% to about 50% ethanol in water. For example, ethanol from about 35% or about 40% in water. In a preferred embodiment, the extraction solvent is an ethanol - water mixture with about 80% ethanol and about 20% water.

[0025] In one embodiment, the extraction temperature is in the range of about 20°C to about 100°C. In a particular embodiment, the temperature for extraction is in the range of about 50°C to about 70°C. Typically, the ratio of plant material to the mixed solvent used in the extraction process varies on a gram-to-milliliter basis, from about 1:1 to about 1:10, about 1:3 to about 1:8, and so on. The incubation period (i.e., the period during which the plant material is in contact with the solvent) is typically from about 2 hours to about 24 hours.

[0026] After the plant material and solvent have been incubated, the solvent is separated from the remaining plant material, and the extract is concentrated (i.e., the solvent is removed) until the extract contains solid components.

[0027] Typically, the solid components may contain (or essentially consist of) ginsenosides and other components in amounts ranging from about 1% to about 35%, and may also include terpenes, phenolic compounds, amino acids, flavonoids, volatile oils, vitamins, and minerals, etc. This natural extract containing ginsenosides and other natural components can be used for the formulation of the compositions of the present invention.

[0028] However, after the extraction process is complete, the ginsenoside(s) can be isolated (i.e., purified) from the extract using a suitable purification process, such as a chromatography process.

[0029] For example, purified ginsenosides may be obtained using the following process: Ginsenosides contained in natural sources such as Panax ginseng, Panax notoginseng, and / or Panax quinquefolius powder (i.e., obtained by preparing ground roots) are dissolved in alcohol, and the ginsenosides are extracted from the powder by alcohol.

[0030] The alcohol is then evaporated, and the remaining residue containing ginsenosides (one or more) is loaded onto a chromatography column filled with reversed-phase C-18 resin;

[0031] - Several fractions containing various compounds are eluted using a series of water and 10% MeOH / 90% water and MeOH systems. These fractions are then compared by high-performance liquid chromatography (HPLC), and their eluates with similar HPLC patterns are combined; - The combined fractions are separated on a standard phase silica gel column chromatography and eluted with chloroform (CHCl3)CHC;

[0032] A methanol mixture starting with -90%, 80% CHCI3 and progressing to 100% MeOH yields several subfractions. The subfractions are compared by HPLC, and fractions containing ginsenosides(single or multiple) are combined. The combined fractions are further purified by a combination of column chromatography on C-18, MCIGELCHP-20P and / or Sephadex LH-20 resin to provide pure ginsenosides(single or multiple). As used herein, the terms “isolated” and “purified” refer to extracts or ginsenosides(single or multiple) that have been isolated from at least one other component (e.g., polypeptides or cellulose derivatives) present in the extract or ginsenosides(single or multiple) in the natural source.

[0033] In one embodiment, the extract or ginsenoside(s)

[0034] In addition, as described by Kazuyoshi Kitaoka et al. (Sleep. 2009 Mar 1; 32(3): 413-421), the fermentation process can be used. A culture medium containing Ag mixture and fermenting organisms is prepared.

[0035] In a preferred embodiment, the fermenting microorganism is a safety-verified probiotic. In a preferred embodiment, the fermenting microorganism is L. paracasei A221, an allofermentable lactic acid bacterium isolated from traditional fermented foods. Its 16S rRNA sequence has been deposited in the GenBank database under accession number AB126872. The Lactobacillus genus is used as a starter for fermented foods, including yogurt and cheese. Their safety as probiotics has been traditionally established. L. paracasei A221 hydrolyzed plant glycosides, including ginsenosides, glycyrrhizine (Glycyrrhizae Radix), and soy isoflavone glycosides (Glycine max). Regarding ginsenosides, L. paracasei A221 hydrolyzed ginsenosides Rb1, Rb2, Rc, and Rd (protopanaxadiol-type), as well as ginsenosides Rg1 and Re (protopanaxatriol-type).

[0036] The culture medium typically contains a natural source of ginsenosides (preferably ground root, such as Panax ginseng, Panax notoginseng, and / or Panax quinquefolius), and other components necessary for the fermentation microorganisms for the fermentation process (i.e., 15% AG, 84%; yeast extract [Asahi Food - Healthcare Co., Ltd, Japan] 6.5%; soy peptide [Fuji Oil Co., Ltd, Japan] 3% and calcium carbonate 6.5%). The fermentation process conditions (temperature, fermentation time, etc.) are determined by those skilled in the art to obtain concentrations of ginsenosides greater than 3%, 5%, 6%, 7%, 8%, 9%, 10%, 13%, 15%, 18%, 20%, 30%, 40%, 60%, 70%, 80%, and 99%. For example, the temperature used can be from 20°C to about 80°C, from 20°C to about 50°C, preferably about 28°C. The fermentation time can be determined by those skilled in the art to obtain a ginsenoside concentration of more than 3%. The fermentation time can be from about 2 hours to about 10 hours, from about 4 hours to about 20 hours, or from about 1 day to about 10 days.

[0037] After fermentation, the culture medium can be sterilized using methods known in the prior art (i.e., 121°C for 10 minutes) and spray-dried. The remainder of yeast cells and other cellular components (such as plant cellulose, etc.) can be removed before or after the sterilization process using separation techniques known in the prior art (i.e., filtration). The fermented culture medium before or after sterilization can be processed using the extraction, isolation, and purification methods described herein to obtain extracts of AG with ginsenoside concentrations of over 3%, over 4%, 5%, 6%, 7%, 8%, 9%, 10%, 13%, 15%, 18%, 20%, 30%, 40%, 60%, 70%, 80%, and over 99%.

[0038] Ginsenosides (singular or plural) can be of synthetic origin. Furthermore, biotechnology can be used for ginsenoside biosynthesis, as reported in Wang, P. et al. (Wang, P. Wei, W., Ye, W. et al. Synthesizing ginsenoside Rh2 in Saccharomyces cerevisiae cell factory at high-efficiency. Cell Discov 5, 5 (2019)). The resulting ginsenosides can be purified using the purification techniques already described herein.

[0039] A composition containing ginsenosides (or the first composition of the present invention) may have a purity (based on total ginsenosides) from about 3% to about 100% by weight, for example, from 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, or 100% of the total ginsenosides in the composition to about 95%, 85%, 75%, 70%, 65%, 60%, 55%, 50%, 40%, 35%, 30%, 25%, 20%, 15%, or 10%. In a preferred embodiment, the total ginsenosides are from about 9% to about 15% by weight, and in a more preferred embodiment, the total ginsenosides are from about 10% to about 13% by weight.

[0040] In one embodiment, a composition comprising a ginsenoside (or the first composition of the present invention) may comprise (or essentially consist of) the following compounds (ginsenosides): a) Rg1: Approximately 0.5% to 8% by weight of total ginsenosides, preferably approximately 1% to 4% by weight of total ginsenosides, and preferably approximately 2% to 4% by weight of total ginsenosides.

[0041] b) Re: Approximately 4% to 50% of total ginsenosides by weight, approximately 4% to 35% of total ginsenosides by weight, preferably approximately 10% to 20% of total ginsenosides by weight, etc.

[0042] c) Rb1: Approximately 10% to 100% by weight of total ginsenosides, preferably approximately 30% to 80% by weight of total ginsenosides, and preferably approximately 40% to 70% by weight of total ginsenosides.

[0043] d) Rc: Approximately 0.5% to 40% by weight of total ginsenosides, preferably approximately 5% to 35% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0044] e) Rb2: Approximately 0.5% to approximately 20% by weight of total ginsenosides, approximately 2% to approximately 15% by weight of total ginsenosides, preferably approximately 2% to approximately 8% by weight of total ginsenosides, and / or

[0045] f) Rd: Approximately 5% to 50% by weight of total ginsenosides, preferably approximately 9% to 30% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0046] In a preferred embodiment, a composition comprising a ginsenoside (or the first composition of the present invention) comprises: Rg1 in about 3% to 4% by weight of the total ginsenoside, preferably 3.6% by weight of the total ginsenoside; Re in 12% to 17% by weight, preferably 16% by weight of the total ginsenoside; Rb1 in 40% to 50% by weight, preferably 48% by weight of the total ginsenoside; Rc in 12% to 17% by weight, preferably 16% by weight of the total ginsenoside; Rb2 in 2% to 5% by weight, preferably 4% by weight of the total ginsenoside; and / or Rd is 12% to 15% by weight of the total ginsenosides, preferably 14% by weight of the total ginsenosides.

[0047] As stated above, ginsenosides can be of natural origin as well as chemically synthesized ginsenosides. In a preferred embodiment, the ginsenoside is of natural origin, and in a more preferred embodiment, the ginsenoside is extracted from members of the genus Panax, preferably from the roots, such as Panax ginseng, Panax notoginseng, and / or Panax quinquefolius. To avoid misunderstanding, ginsenosides can be obtained not only from Panax quinquefolius, Panax ginseng, or Panax notoginseng, but also from any proportion of two of them (i.e., Panax ginseng and Panax notoginseng, Panax notoginseng and Panax quinquefolius), or from all three: Panax ginseng, Panax notoginseng, and Panax quinquefolius. To avoid misunderstanding, ginsenosides can be just one type of ginsenoside, or a mixture of two or more of the various ginsenosides reported in the literature, such as Rb1, Rb2, Rb3, Rc, Re, Rf, Rg1, Rg2, Rhl, Ro, etc.

[0048] Extracts and processes for obtaining extracts In accordance with the present invention, an extract of Panax quinquefolius (American ginseng) (AG) (particularly a Panax quinquefolius leaf-stem or root extract) is provided, which may hereafter be referred to as "the extract of the present invention" herein.

[0049] Typically, the extracts of the present invention may also be extracts obtained from American ginseng (particularly the root of AG) using the processes described herein. To avoid misunderstanding, all references to Panax quinquefolius (AG) extracts herein will refer to extracts obtained from, among other things, AG leaf-stem or root (more specifically, root) extracts. The extract of the present invention may also be the crushed root of American ginseng, which contains between approximately 3 and 15% ginsenosides.

[0050] Other methods for preparing the extract of the present invention may include water extracts, alcohol extracts, or water-alcohol extracts. Preferably, the extract of the present invention is a water-alcohol extract, such as a water-methanol or water-ethanol extract. For example, the extract of the present invention may be a water-ethanol extract obtained using an extraction solvent containing about 1% to about 99% ethanol in water, such as about 30% to about 75% ethanol in water, or about 30% to about 50% ethanol in water, such as about 35% or about 40% ethanol in water.

[0051] As used herein, the term “water extract” refers to an extract obtained from Panax quinquefolius (AG) when the extraction from the plant (in particular the roots) is carried out using water as the sole solvent.

[0052] As used herein, the term “alcohol extract” refers to an extract obtained from Panax quinquefolius (AG) when the extraction from the plant (in particular, the roots) is carried out using alcohol as the sole solvent, e.g., 100% methanol or 100% ethanol. As used herein, the term “water-alcohol extract” refers to an extract obtained from Panax quinquefolius (AG) when the extraction from the plant is carried out using a mixture of water and alcohol, e.g., from about 1% water to about 99% alcohol (ethanol, for example), such an extract is called a water-ethanol extract.

[0053] The extracts of the present invention may be isolated from American ginseng (particularly the root of AG) using separation techniques to select the desired extract, which may be determined by those skilled in the art. Typically, the extracts of the present invention may be obtained by the extraction and isolation processes generally described herein, or by modifications of those routines. For example, the process for extraction and isolation of the extract of the present invention may include (essentially consist of / consist of) the following steps: (i) Extraction of the roots of Agnus gracilis (which may be ground) with a suitable solvent; (ii) Evaporation of the solvent; and; if required (iii) Purification of the extract (for example, by chromatography).

[0054] Typically, the roots of AG are ground into granules with particle sizes ranging from approximately 0.1 mm to 30 mm, increasing the surface area in contact with the solvent and thus increasing extraction efficiency.

[0055] Special solvents that may be used in the extraction process include alcohols (such as methanol) and alcohol / water mixtures (such as a mixture of methanol and water). For example, the extraction solvent can be water, a water-alcohol mixture (about 1% to about 99% alcohol in water, e.g., about 30% to about 75% alcohol in water, or about 30% to about 50% alcohol in water, or about 35% to about 40% alcohol in water, etc.), or alcohol. Special alcohols that may be mentioned include ethanol (EtOH) and methanol (MeOH).

[0056] In a particular embodiment, the extraction solvent may be an ethanol-water mixture, such as ethanol in water at a concentration of about 30% to about 75%, or ethanol in water at a concentration of about 30% to about 50%. For example, ethanol at a concentration of about 35% or about 40% in water.

[0057] In one embodiment, the extraction temperature is in the range of approximately 20°C to approximately 100°C. In certain embodiments, the temperature for extraction ranges from approximately 50°C to approximately 70°C. Typically, the ratio of plant material to the mixed solvent used in the extraction process varies on a gram-to-milliliter basis, from approximately 1:1 to approximately 1:10, approximately 1:3 to approximately 1:8, and so on. The incubation period (i.e., the period during which the plant material is in contact with the solvent) is typically from approximately 2 hours to approximately 24 hours.

[0058] After the plant material and solvent have been incubated, the solvent is separated from the remaining plant material, and the extract is concentrated (i.e., the solvent is removed) until the extract contains solid components. Typically, the solid components may contain (or consist essentially of) about 1% to about 35% AG ginsenosides. Other components include terpenes, phenolic compounds, amino acids, flavonoids, volatile oils, vitamins, and minerals. After the completion of the extraction process, the ginsenoside(s)

[0059] Typically, the extract of the present invention may be obtained by the following process: -AG extract powder (i.e., obtained by preparing ground roots) is dissolved in alcohol and ginsenosides (single or multiple) and extracted from the powder with alcohol.

[0060] The alcohol is then evaporated, and the remaining residue containing ginsenosides (one or more) is loaded onto a chromatography column filled with reversed-phase C-18 resin;

[0061] - Several fractions containing various compounds are eluted with a series of water and 10% MeOH / 90% water and MeOH systems. The fractions are compared by high-performance liquid chromatography (HPLC) analysis, and their elutes with similar HPLC patterns are combined;

[0062] - The combined fractions are separated on normal-phase silica gel column chromatography and eluted with chloroform (CHCI3), 90%, 80% CHCI3, and CHC-methanol mixtures up to 100% MeOH to give several sub-fractions. The sub-fractions are compared by HPLC, and fractions containing ginsenosides(single or multiple) are combined. The combined fractions are further purified by a combination of column chromatography on C-18, MCIGELCHP-20P, and / or Sephadex LH-20 resins to provide pure ginsenosides(single or multiple). As used herein, the terms “isolated” and “purified” refer to extracts or ginsenosides(single or multiple) that have been isolated from at least one other component (e.g., polypeptides or cellulose derivatives) present in the extract or ginsenosides(single or multiple) in the natural source. In one embodiment, the extract or ginsenoside(s)(s)(s)(s)(s)(s)(s)(s)(s))(s)))))))

[0063] In addition, as described by Kazuyoshi Kitaoka et al. (Sleep. 2009 Mar 1; 32(3): 413-421), a fermentation process can be used. A culture medium containing an Ag mixture and fermenting organisms is prepared. In a preferred embodiment, the fermenting microorganism is a safety-verified probiotic. In a preferred embodiment, the fermenting microorganism is L. paracasei A221, an alloferrous lactic acid bacterium isolated from traditional fermented foods. Its 16S rRNA sequence has been deposited in the GenBank database under accession number AB126872. Lactobacillus bacteria are used as starters for fermented foods, including yogurt and cheese. Their safety as probiotics has been traditionally established. L. paracasei A221 hydrolyzed plant glycosides, including ginsenosides, glycyrrhizine (Glycyrrhizae Radix), and soy isoflavone glycosides (Glycine max). Regarding ginsenosides, L. paracasei A221 hydrolyzed ginsenosides Rb1, Rb2, Rc, and Rd (protopanaxadiol-type), as well as ginsenosides Rg1 and Re (protopanaxatriol-type).

[0064] The culture medium typically contains AG (ground AG is preferred) and other necessary components from fermenting microorganisms for the fermentation process (i.e., 15% AG, 84%; yeast extract [[Asahi Food - Healthcare Co., Ltd, Japan] 6.5%; soy peptide [Fuji Oil Co., Ltd, Japan] 3%; and calcium carbonate 6.5%). The fermentation process conditions (temperature, fermentation time, etc.) are determined by those skilled in the art to obtain concentrations of ginsenosides greater than 3%, greater than 5%, 6%, 7%, 8%, 9%, 10%, 13%, 15%, 18%, 20%, 30%, 40%, 60%, 70%, 80%, and 99%. For example, the temperature used can be from 20°C to about 80°C, from 20°C to about 50°C, preferably about 28°C. The fermentation time can be determined by those skilled in the art to obtain a ginsenoside concentration greater than 3%. Fermentation times can range from approximately 2 hours to 10 hours, from approximately 4 hours to 20 hours, and from approximately 1 day to 10 days. After fermentation, the culture medium can be sterilized using methods known in the prior art (i.e., 121°C for 10 minutes) and spray-dried. The remainder of yeast cells and other cellular components (such as plant cellulose, etc.) can be removed before or after the sterilization process using separation techniques known in the prior art (i.e., filtration). The fermented culture medium before or after sterilization can be processed using the extraction, isolation, and purification methods described herein to obtain extracts of AG with ginsenoside concentrations of over 3%, over 4%, 5%, 6%, 7%, 8%, 9%, 10%, 13%, 15%, 18%, 20%, 30%, 40%, 60%, 70%, 80%, and over 99%.

[0065] Therefore, the terms “isolated” and “purified” do not refer to extracts or ginsenosides present in their natural sources. Similarly, the term “extract” refers to components of a natural material obtained through the extraction process, rather than those components present in their natural sources (for example, as AG root). In a special embodiment, the extract of the present invention obtained by such method may be as follows: There are virtually no other plant materials (for example, no plant cellulose); Substantially absent plant cells; and / or It is virtually free of plant cell substances, quintozenes, aflatoxins, ochratoxin A, cadmium, arsenic, or mercury.

[0066] When used herein, a reference to a material in which another material is "substantially absent" may mean a material in which the other material constitutes less than 1% by weight (less than 0.1%, such as less than 0.01% or less than 0.001% by weight).

[0067] In an alternative embodiment, a method for extracting and isolating an AG extract from the roots of AG may be described as including (or essentially consisting of / consisting of) the following steps: (a) Grind the AG roots into particles; (optionally carry out the fermentation process as described above) (b) To contain particles in a mixed solvent; (c) Separating the ground particles from the mixed solvent; and (d) Evaporate the mixed solvent. In this embodiment, the process may include (or essentially consist of) the following steps: (e) Dissolving the product of (d) in alcohol; and (f) Evaporating alcohol.

[0068] Typically, in the extraction of an AG extract from the roots of AG (i.e., steps (a) to (d) as described herein above): the ground particles have a diameter of about 0.1 mm to 30 mm; and / or the temperature is from about 20°C to about 100°C; and / or the ratio of ground particles to mixed solvent is from about 1 g to 1 ml to about 1 g to 8 ml; and / or the ground particles are in contact with the mixed solvent for about 2 hours to about 24 hours; and / or the mixed solvent is water, a water-alcohol mixture, or alcohol.

[0069] In a particular embodiment, the extract of the present invention as described herein may be an extract obtained (or obtained by) the process as described herein.

[0070] Those skilled in the art will understand methods for preparing ginseng extract using various extraction techniques (other powders, extracts, and modified products) to obtain ginsenoside-containing ginseng.

[0071] Ginsenosides can be classified into three groups based on their chemical structure: the panaxadiol group (Rb1, Rb2, Rb3, Rc, etc.), the panaxatriol group (Re, Rf, Rg1, Rg2, RhI), and the oleanolic acid group (Ro, for example). American ginseng (Panax quinquefolius) has its own characteristic profile, exhibiting high expression of ginsenoside Rb1. The Panax quinquefolius extract of the present invention may have a purity (based on total ginsenosides) ranging from about 3% to about 100% by weight, with total ginsenosides in the extract ranging from 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90%, to about 95%, 85%, 75%, 70%, 65%, 60%, 55%, 50%, 40%, 35%, 30%, 25%, 20%, 15%, or 10%. In a preferred embodiment, the total ginsenosides range from about 9% to about 15% by weight, and in a more preferred embodiment, the total ginsenosides range from about 10% to about 13% by weight. In one embodiment, the extract of the invention may contain (or essentially consist of) the following compounds (ginsenosides): a) Rg1 in amounts of approximately 0.05% to approximately 0.8% by weight, preferably approximately 0.3% to approximately 0.5% by weight, such as approximately 0.1% to approximately 0.4% by weight. b) Re c) Rb1 of about 1% to about 10% by weight, preferably about 4% to about 7% by weight, such as about 3% to about 8% by weight d) Rc in an amount of approximately 0.1% to approximately 5% by weight, preferably approximately 0.5% to approximately 3.5% by weight, such as approximately 0.3% to approximately 4% by weight. e) Rb2 in amounts of approximately 0.1 to 3% by weight, preferably approximately 0.2% to 1.5% by weight, such as approximately 0.5% to approximately 2% by weight, and / or f) Rd of approximately 0.5% to approximately 5% by weight, preferably approximately 0.9% to approximately 3% by weight, such as approximately 0.7% to approximately 4% by weight.

[0072] In a preferred embodiment, the AG extract contains about 10% to 13% by weight, preferably about 10% ginsenosides, and the specific ginsenoside concentrations by weight are as follows: about 0.1% to 0.4%, preferably 0.36% Rg1; 0.4% to 3.5%, preferably 1.6% Re; 14% to 7%, preferably 4.8% Rb; 0.5% to 3.5%, preferably 1.6% Rc; 20.2% to 1.5%, preferably 0.4% Rb; and / or 0.9% to 3%, preferably 1.4% Rd. Unless otherwise specified herein, the weight percentages listed are based on the total weight of the obtained (dried) extract.

[0073] In one embodiment, the extract of the invention may contain (or essentially consist of) the following compounds (ginsenosides): a) Rg1: Approximately 0.5% to 8% by weight of total ginsenosides, preferably approximately 1% to 4% by weight of total ginsenosides, and preferably approximately 3% to 4% by weight of total ginsenosides.

[0074] b) Re: Approximately 4% to 50% of total ginsenosides by weight, approximately 4% to 35% of total ginsenosides by weight, preferably approximately 10% to 20% of total ginsenosides by weight, etc.

[0075] c) Rb1: Approximately 10% to 100% by weight of total ginsenosides, preferably approximately 30% to 80% by weight of total ginsenosides, and preferably approximately 40% to 70% by weight of total ginsenosides.

[0076] d) Rc: Approximately 1% to 40% by weight of total ginsenosides, preferably approximately 5% to 35% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0077] e) Rb2: Approximately 1% to approximately 20% by weight of total ginsenosides, approximately 2% to approximately 15% by weight of total ginsenosides, preferably approximately 2% to approximately 8% by weight of total ginsenosides, and / or

[0078] f) Rd: Approximately 5% to 50% by weight of total ginsenosides, preferably approximately 7% to 30% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0079] In a preferred embodiment, the AG extract contains: Rg1 at about 3% to 4% by weight of the total ginsenosides, preferably 3.6% by weight of the total ginsenosides; Rb1 at 12% to 17% by weight of the total ginsenosides, preferably 16% by weight; Re at 40% to 50% by weight of the total ginsenosides, preferably 48% by weight; Rc at 12% to 17% by weight of the total ginsenosides, preferably 16% by weight; Rb2 at 2% to 5% by weight of the total ginsenosides, preferably 4% by weight; and / or Rd at 12% to 15% by weight of the total ginsenosides, preferably 14% by weight of the total ginsenosides.

[0080] To avoid misunderstanding, selections, options, special features, and other similar items are indicated for a given aspect, feature, or parameter of the Invention and should be deemed to have been disclosed in combination with any and all other selections, options, special features, and other similar items as indicated for the same or other aspects, features, and parameters of the Invention, unless otherwise indicated in the context.

[0081] When the terms "comprising" or "comprises" are used, it means that the described extract or composition must contain the listed components (singular or plural), but may optionally contain additional components. When the terms "consisting essentially of" or "consists essentially of" are used, the described extract or composition must contain the listed components (singular or plural), and may contain small amounts of other components (e.g., up to 5% by weight, or 1% or 0.1% by weight) if any additional components do not affect the basic properties of the extract or composition. When the terms "consisting of" or "consists of" are used, it means that the described extract or composition must contain only the listed components (singular or plural). As used herein, the term “about” means, for example, a change of ±20%, ±10%, ±5%, ±1%, ±0.5%, or in particular ±0.1% of a specified amount, when referring to a measurable value (such as the amount or weight of a particular component in a reaction mixture).

[0082] Furthermore, other compounds may be present in the extract of the present invention. In some embodiments, other compounds that may be present include, but are not limited to, terpenes, phenolic compounds, amino acids, flavonoids, volatile oils, vitamins, and minerals.

[0083] Those skilled in the art will understand that the extracts of the present invention may be provided in solid form. Depending on the solid form, the compound may be provided as an amorphous solid, or as a crystalline or partially crystalline solid.

[0084] Composition and administration In accordance with the present invention, compositions comprising the ginsenoside of the present invention, or extracts of the present invention, may be provided in the form of (preferred) compositions, such as pharmaceuticals, nutritional supplement compositions, or food compositions (which may be referred to as functional food compositions or dietary compositions).

[0085] In particular embodiments, compositions comprising the ginsenoside of the present invention, or extracts of the present invention, may be provided as appropriate in the form of pharmaceutical compositions (which may be referred to as pharmaceutical formulations), nutritional supplement compositions or functional food compositions comprising extracts of the present invention, and optionally pharmaceutically acceptable excipients or acceptable components of (functional) foods.

[0086] When used herein, references to pharmaceutically acceptable additives may refer to pharmaceutically acceptable auxiliaries, diluents, and / or carriers known to those skilled in the art.

[0087] Food-acceptable components include those known in the art (including those referred to herein as pharmaceutically acceptable additives), and they may be natural or non-natural, meaning their structures may or may not occur naturally. In some examples, they may arise from natural compounds and be subsequently modified (e.g., maltodextrin). In a particular embodiment, a composition comprising the ginsenoside of the present invention, or an extract of the present invention, may be provided in the form of a pharmaceutical composition or a functional food composition, further comprising a non-natural carrier or a modified natural carrier, such as maltodextrin or gum arabic. In a preferred embodiment, the extract of the present invention is formulated with maltodextrin, and in another preferred embodiment, the extract of the present invention is formulated with gum arabic.

[0088] The term "pharmaceutically acceptable" means that any additional components of the composition are sterile and pyrogen-free. Such components must be "acceptable" in the sense that they are compatible with the extracts of the present invention and must not be harmful to their recipients. Thus, "pharmaceutically acceptable" includes any compounds used in forming part of a formulation that is intended to act merely as an additive, i.e., not intended to have biological activity itself. Thus, pharmaceutically acceptable additives are generally safe, non-toxic, and not biologically, or at least, undesirable. Those skilled in the art will understand that the extracts of the present invention (in the form of compositions, such as those described herein, e.g., pharmaceutical compositions known to those skilled in the art) may be administered to a patient or subject (e.g., a human or animal patient or subject) by any preferred route, such as orally, rectally, nasally, pulmonaryly, orally, sublingually, percutaneously, intracisionally, intraperitoneally, and parenterally (including subcutaneously, intramuscularly, intramedullarily, intravenously, and intradermally) routes. In particular, the extracts of the present invention may be administered orally. In such examples, the pharmaceutical or nutritional supplement composition according to the present invention may be specifically formulated for administration via the oral route.

[0089] Pharmaceutical and nutritional supplement compositions for oral administration include solid dosage forms such as hard or soft capsules, tablets, lozenges, sugar-coated preparations, pills, powders, and granules. If necessary, they may be prepared by coatings such as enteric coatings, or they may be formulated to provide release control, such as sustained or prolonged release of the active ingredient, according to methods well known in the prior art. Liquid dosage forms for oral administration include solutions, emulsions, aqueous or oily suspensions, syrups, and elixirs.

[0090] Compositions described herein (e.g., pharmaceuticals, dietary supplements, or food compositions) intended for oral administration may be prepared by bringing the components of the composition into a mixture according to methods known to those skilled in the art.

[0091] Such compositions described herein may contain one or more additional components selected from the group consisting of food components, such as sweeteners, flavoring additives, colorants, and preservatives. The tablets may contain an active ingredient mixed with non-toxic, pharmaceutically acceptable additives (or components) suitable for the manufacture of tablets. These excipients (or components) may include, for example: inert diluents such as calcium carbonate, sodium carbonate, lactose, calcium phosphate, or sodium phosphate; granulating and disintegrating agents, such as corn starch, maltodextrin, or alginic acid; binders, such as starch, gelatin, or acacia; and smoothing agents, such as magnesium stearate, stearic acid, or talc. The tablets may not be coated, or they may be coated by known techniques for delaying disintegration and absorption in the gastrointestinal tract and thereby providing a sustained action over a long period of time. For example, time-delaying materials such as glyceryl monostearate or glyceryl distearate may be used.

[0092] Suitable pharmaceutical carriers include inert solid diluents or fillers, sterile aqueous solutions, and various organic solvents. Examples of solid carriers are lactose, clay, sucrose, cyclodextrin, maltodextrin, talc, gelatin, silica, agar, pectin, acacia, magnesium stearate, stearic acid, gum arabic, modified starch, and lower alkyl ethers of cellulose. Examples of liquid carriers are syrup, peanut oil, olive oil, phospholipids, fatty acids, fatty acid amines, polyoxyethylene, and water. Furthermore, the carrier or diluent may contain any sustained-release material known in the art, such as glyceryl monostearate or glyceryl distearate, either alone or mixed with wax.

[0093] Similar to the route of administration, the extracts of the present invention may be administered in modified doses (i.e., therapeutically effective doses when administered to patients in need) to be treated according to the disorder and patient. In this regard, those skilled in the art will recognize that, in the context of the present invention, the dose administered to mammals, particularly humans, must be sufficient to influence the therapeutic response in the mammal over a reasonable time frame. Those skilled in the art will also recognize that the selection of the precise dose and composition, and the most appropriate delivery therapy, will also be influenced, among other things, by the pharmacological properties of the formulation, the nature and severity of the condition being treated, and the physical and mental condition of the recipient, as well as the capabilities of the specific compound, age, condition, weight, sex, and the response of the patient being treated, and the stage / severity of the disease.

[0094] Typically, in the use or methods of the invention described herein, an extract or composition containing the extract of the present invention, or a composition containing the ginsenoside of the present invention, is administered in amounts ranging from about 100 mg / day to about 2000 mg / day, or from about 500 mg / day to about 1500 mg / day, or from about 1000 mg / day. In a preferred embodiment, the amount is from about 100 mg / day to about 400 mg / day, more preferably from about 150 mg / day to about 250 mg / day, and more preferably 200 mg / day. In any case, a practitioner or other person skilled in the art will be able to routinely determine the actual dosage, and it will be most suitable for the individual patient. The above doses are illustrative examples for the average case; of course, there may be individual examples of higher or lower dosage ranges, but it is within the scope of the present invention.

[0095] When included in compositions described herein (for example, pharmaceutical compositions), the compositions comprising the ginsenoside of the present invention, or the extracts of the present invention, are typically present in amounts ranging from about 1% by weight to about 100% by weight, for example, from about 10% by weight to about 90% by weight, or from about 20% by weight to about 80% by weight, or from about 30% by weight to about 70% by weight, or from about 40% by weight to about 60% by weight. Functional food compositions can be presented as beverages, dairy products, bakery products, and so on.

[0096] Use and method of the present invention Compositions comprising the ginsenoside or extract of the present invention (and pharmaceutical, nutritional supplement, or food composition of the present invention) may have an effect in reducing fatigue (as shown in Figure 9). Compositions comprising the ginsenoside or extract of the present invention may have an effect in improving the mood of the subject. Typically, the extract of the present invention may reduce negative emotions and increase self-confidence (as shown in Figure 10). Furthermore, compositions comprising the ginsenoside or extract of the present invention may increase attention and agility after chronic treatment (as shown in Figures 2, 3, 4, 5, 6, 7, and 8).

[0097] As used herein, the term “fatigue” may refer to the general feeling of exhaustion or a lack of energy in a healthy subject, but it may also be associated with several medical conditions. Fatigue is a common symptom of many medical conditions, ranging in severity from mild to severe. Many medical conditions can also cause fatigue. Examples include: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism, or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema. Fatigue can also be described as a condition in which the subject experiences, in particular, a feeling of sleepiness, fatigue, sluggishness, and / or drowsiness.

[0098] Fatigue (a general lack of energy) can be measured using standard methods known to those skilled in the art. Examples of methods that can be used include, but are not limited to, the PANAS-X (Watson, D., & Clark, LA (1994). The PANAS-X: Manual for the positive and negative affect schedule-expanded form) and the mental fatigue visual analogue scale (Scholey, AB, French, SJ, Morris, PJ, Kennedy, DO, Milne, AL, & Haskell, CF (2010). Journal of Psychopharmacology, 24(10), 1505-1514).

[0099] The PANAS-X scale consists of numerous words describing a range of sensations and feelings, including confidence (sleepy, tired, sluggish, drowsy). Participants read each item and then record the appropriate response (giving a score from 1 to 5) in the following space, indicating how much they felt this way during the previous week. A higher rating indicates a higher level of fatigue.

[0100] Fatigue can also be measured via a mental fatigue visual analog scale: participants rate their current subjective state of mental fatigue by marking on a 9-point Likert scale, ranging from "not at all" (far left) to "very much" (far right) (Scholey, AB, French, SJ, Morris, PJ, Kennedy, DO, Milne, AL, & Haskell, CF (2010) Journal of Psychopharmacology, 24(10), 1505-1514).

[0101] As used herein, the terms “attention” and “agility” are interchangeable and may refer to an overall state of heightened awareness or heightened focus, as well as concentration or decision-making, in a healthy subject and in relation to several medical conditions. Deficiency of attention / agility is a common symptom of many medical conditions, ranging in severity from mild to severe. Many medical conditions can also cause deficits of attention / agility. Examples include: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism, or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema. Attention and agility can also be described as the ability to handle highly cognitive tasks, including but not limited to response time for processing correct answers to complex information or complex tasks requiring the synthesis of multiple pieces of information. Attention / agility states can be measured using standard methods known to those skilled in the art. Examples of methods that can be used include, but are not limited to, accuracy and response time in a modified attention network task as described in the examples of this application. Attention and agility can also be described as the ability to handle highly cognitive tasks, such as Rapid Visual Information Processing tasks. In this sustained attention task, a sequence of digits is presented on a screen without interruption. Participants are asked to monitor digits relating to sequences of three consecutive even or three consecutive odd digits. Participants point to the end of the target sequence by pressing the spacebar as quickly as possible.The dependent variables are response time, accuracy, and commission error (Watson, AW, Haskell-Ramsay, CF, Kennedy, DO, Cooney, JM, Trower, T., & Scheepens, A. (2015). Acute supplementation with blackcurrant extracts modulates cognitive functioning and inhibits monoamine oxidase-B in healthy young adults. Journal of functional foods, 17, 524-539.).

[0102] As used herein, the term “confidence” may refer to the overall sense of being confident, proud, strong, bold, fearless, and courageous in a healthy person or in relation to some medical conditions. Lack of confidence is a common symptom of many medical conditions, ranging in severity from mild to severe. Many medical conditions can also cause a decrease in confidence. Examples include: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism, or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema. Confidence may also be described as the ability to overcome difficulties by surpassing oneself. The state of confidence can be measured using standard methods known to those skilled in the art. Examples of methods that can be used include, but are not limited to, the PANAS-X (Watson, D., & Clark, LA (1994). The PANAS-X: Manual for the positive and negative affect schedule-expanded form) as described in the examples of this application. This scale consists of numerous words describing a range of feelings and emotions, including confidence (proud, strong, confident, bold, fearless, courageous). Participants read each item and then record the appropriate response (giving a score from 1 to 5) in the following space. This indicates how much they felt this way during the previous week. A higher rating indicates a higher state of confidence.

[0103] Accordingly, in one aspect of the present invention, a composition comprising the ginsenoside or Panax quinquefolius extract of the present invention (i.e., the extract of the present invention) is provided for the following uses: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving or increasing attention / agility; and / or (c) improving or increasing self-confidence. Certain aspects disclosed herein provide a compound or composition comprising a composition comprising the ginsenoside or Panax quinquefolius extract of the present invention. Such a compound or composition (e.g., a pharmaceutical, dietary supplement, or food composition) is useful for reducing, defending against, and / or improving fatigue. In a further aspect of the present invention, compounds or compositions comprising a ginsenoside or Panax quinquefolius extract of the present invention, or a composition comprising a ginsenoside or Panax quinquefolius extract of the present invention (e.g., a pharmaceutical, dietary supplement, or food composition) for the following uses: (a) treating, reducing, defending against, and / or improving fatigue in a subject; (b) improving or increasing attention / agility in a subject; and / or (c) improving or increasing self-confidence in a subject. In one embodiment, the subject is a human.

[0104] In a further preferred embodiment, the subject is a healthy subject, and in a more preferred embodiment, the subject is a healthy human being. In a further aspect of the present invention, compounds or compositions comprising a composition comprising the ginsenoside of the present invention or Panax quinquefolius extract, or a composition comprising the ginsenoside of the present invention or Panax quinquefolius extract (e.g., a pharmaceutical, dietary supplement, or food composition) for the following uses in a subject: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving or increasing attention / agility; and / or (c) improving or increasing self-confidence. In one embodiment, the subject is a human being. In a further preferred embodiment, the subject is a healthy subject, and in a more preferred embodiment, the subject is a healthy human being.

[0105] In one embodiment, the use of a compound or composition comprising a ginsenoside or Panax quinquefolius extract of the present invention, or a composition comprising a ginsenoside or Panax quinquefolius extract of the present invention, for the following purposes in a subject: (a) to treat, reduce, protect against, and / or improve fatigue in the subject; (b) to improve or increase attention / agility in the subject; and / or (c) to improve or increase confidence. In one aspect, the subject is human beings.

[0106] In one embodiment, a compound or composition (e.g., a pharmaceutical, dietary supplement, or food composition) is provided for the following in a subject by administration of the compound or composition: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving or increasing attention / agility; and / or (c) improving or increasing confidence or its symptoms, wherein the compound or composition (e.g., a pharmaceutical, dietary supplement, or food composition) includes a ginsenoside or a composition comprising an extract of Panax quinquefolius according to the present invention. In a further alternative aspect of the present invention, the following methods are provided: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving or increasing attention / agility; and / or (c) improving or increasing confidence, including administering an effective amount of a compound or composition (e.g., a pharmaceutical, dietary supplement, or food composition) comprising a composition comprising a ginsenoside or Panax quinquefolius extract of the present invention, or a composition comprising a ginsenoside or Panax quinquefolius extract of the compound of the present invention, to a subject in need thereof. In one embodiment, the subject is a human. In a further preferred embodiment, the subject is a healthy subject, and in an even more preferred embodiment, the subject is a healthy human being.

[0107] In an alternative aspect of the present invention, the use of a compound or composition comprising a ginsenoside or Panax quinquefolius extract of the present invention, or a composition comprising a ginsenoside or Panax quinquefolius extract of the present invention, in the manufacture or preparation of a drug or nutritional supplement composition for the following in a subject: (a) treating, reducing, defending against, and / or improving fatigue; (b) improving attention / agility; and / or (c) improving or increasing self-confidence in a subject. In one embodiment, the subject is a human. In a further preferred embodiment, the subject is a healthy subject, and in a more preferred embodiment, the subject is a healthy human.

[0108] In a further embodiment, a method is provided for treating, preventing, delaying, or improving fatigue in a subject who has or is at risk of having fatigue, comprising administering to a subject a composition comprising the ginsenoside of the present invention, or a Panax quinquefolius extract, or a composition comprising the AG extract (e.g., a pharmaceutical, nutritional supplement, or food composition), thereby preventing, delaying, or improving fatigue in the subject. In one embodiment, the subject is a human. In a further preferred embodiment, the subject is a healthy subject, and in a more preferred embodiment, the subject is a healthy human. In another embodiment, the subject is not healthy and fatigue is related to a medical condition.

[0109] In further embodiments of the uses and methods described above, the subjects are those suffering from one or more of the following medical conditions: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism, or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema.

[0110] In further embodiments of the uses and methods described above, fatigue is associated with one or more of the following medical conditions: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema.

[0111] In one aspect, the treatment, reduction, prevention, and / or improvement of fatigue is achieved by the treatment, reduction, prevention, and / or improvement of feelings of sleepiness, fatigue, dullness, and / or drowsiness.

[0112] Typically, the extracts of the present invention may reduce feelings of drowsiness or fatigue (as shown in Figure 9). Therefore, in a further aspect of the present invention, compositions comprising the ginsenoside or Panax quinquefolius extract of the present invention, or compounds or compositions comprising the ginsenoside or Panax quinquefolius extract of the present invention, are provided for the following uses: a) To reduce the feeling of drowsiness, b) To reduce the feeling of fatigue, c) To reduce dull sensations, and / or d) Reduce the feeling of drowsiness.

[0113] In further embodiments of the uses and methods described above, fatigue is associated with one or more of the following medical conditions: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema.

[0114] The extracts of the present invention may improve the self-confidence of the subject. Typically, the extracts of the present invention may increase feelings of confidence or fearlessness (as shown in Figure 10).

[0115] In further embodiments of the uses and methods described above, the problems or reduction of confidence are related to one or more of the following medical conditions: anemia, arthritis, fibromyalgia, chronic fatigue syndrome, infections such as the common cold and influenza, Addison's disease, hypothyroidism or hypothyroidism, hyperthyroidism, sleep disorders such as insomnia, eating disorders such as anorexia, autoimmune disorders, congestive heart disease, cancer, diabetes, kidney disease, liver disease, chronic obstructive pulmonary disease (COPD), aging, neuropsychiatric disorders such as depression and anxiety, neurodegenerative diseases such as schizophrenia, Alzheimer's disease, Parkinson's disease, or emphysema.

[0116] In one aspect, improvement in self-confidence is due to an increase in a proud feeling, a strong feeling, a confident feeling, a fearless feeling, and / or a courageous feeling.

[0117] Therefore, in one aspect of the present invention, a composition comprising the ginsenoside or Panax quinquefolius extract of the present invention, or a compound comprising the Panax quinquefolius extract, is provided for the following uses: a) To increase a sense of pride, b) To increase the intensity of sensations, c) To increase the feeling of confidence, d) To increase the sense of boldness, e) Increasing the sense of fearlessness, and / or f) To increase the feeling of courage.

[0118] To avoid misunderstanding, in special embodiments of the uses and methods described herein, compositions comprising the ginsenoside or Panax quinquefolius extract of the present invention may contain (or essentially consist of) the following compounds (ginsenosides): from about 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, or 90% of the total ginsenosides in the extract, to about 95%, 85%, 75%, 70%, 65%, 60%, 55%, 50%, 40%, 35%, 30%, 25%, 20%, 15%, or 10% by weight. In a preferred embodiment, the composition comprising the ginsenoside or Panax quinquefolius extract of the present invention is about 9% to about 15% by weight, and in a more preferred embodiment, the total ginsenoside is about 10% to about 13% by weight.

[0119] To avoid misunderstanding, in special embodiments of the uses and methods described herein, compositions comprising the ginsenosides or extracts of the present invention may contain (or essentially consist of) the following compounds (ginsenosides): a) Rg1 from about 0.01% to about 0.8% by weight, preferably from about 0.1% to about 0.4%, such as from about 0.05% to about 0.4% by weight. b) Re, preferably approximately 0.8% to approximately 3.5% by weight, such as approximately 0.1% to approximately 5% by weight, such as approximately 0.4% to approximately 4% by weight. b) Rb1 in amounts of approximately 3% to approximately 8% by weight, preferably approximately 4% to approximately 7% by weight, and about 1% to approximately 10% by weight. c) Rc in an amount of approximately 0.05% to approximately 5% by weight, such as approximately 0.1% to approximately 4% by weight, preferably approximately 0.5% to approximately 3.52% by weight, d) Rb2 in amounts of approximately 0.1% to approximately 2% by weight, preferably approximately 0.2% to approximately 1.5% by weight, or approximately 0.05% to approximately 3% by weight. and / or e) Rd of approximately 0.5% to 5% by weight, preferably approximately 0.9% to 3% by weight, such as approximately 0.7% to 4% by weight.

[0120] In preferred embodiments of the uses and methods described herein, the composition comprising the ginsenoside or AG extract of the present invention comprises, by weight, about 10% to 13%, preferably about 10%, of ginsenoside, and the specific concentrations of the ginsenoside are as follows: Rg1 about 0.1% to 0.4%, preferably 0.36%, Re 0.8% to 3.5%, preferably 1.6%, Rb1 4% to 7%, preferably 4.8%, Rc 0.5% to 3.5%, preferably 1.6%, Rb2 0.2% to 1.5%, preferably 0.4%, and / or Rd 0.9% to 3%, preferably 1.4%. Unless otherwise specified herein, the weight percentages listed are based on the total weight of the obtained (dried) extract.

[0121] To avoid misunderstanding, in special embodiments of the uses and methods described herein, compositions comprising the ginsenoside or AG extract of the present invention may contain (or essentially consist of / consist of) the following compounds (ginsenosides):

[0122] a) Rg1: Approximately 0.5% to 8% by weight of total ginsenosides, preferably approximately 1% to 4% by weight of total ginsenosides, and preferably approximately 3% to 4% by weight of total ginsenosides.

[0123] b) Re: Approximately 5% to 50% of total ginsenosides by weight, approximately 10% to 35% of total ginsenosides by weight, preferably approximately 12% to 20% of total ginsenosides by weight, etc.

[0124] c) Rb1: Approximately 10% to 100% by weight of total ginsenosides, preferably approximately 30% to 80% by weight of total ginsenosides, and preferably approximately 40% to 60% by weight of total ginsenosides.

[0125] d) Rc: Approximately 1% to 40% by weight of total ginsenosides, preferably approximately 5% to 35% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0126] e) Rb2: Approximately 1% to approximately 20% by weight of total ginsenosides, approximately 2% to approximately 10% by weight of total ginsenosides, preferably approximately 2% to approximately 5% by weight of total ginsenosides, and / or

[0127] f) Rd: Approximately 5% to 50% by weight of total ginsenosides, preferably approximately 7% to 30% by weight of total ginsenosides, and preferably approximately 10% to 20% by weight of total ginsenosides.

[0128] In preferred embodiments of the methods and uses described herein, the AG extract contains: Rg1 in about 3% to 4% by weight of the total ginsenosides, preferably 3.6% by weight of the total ginsenosides; Re in 12% to 17% by weight of the total ginsenosides, preferably 16% by weight; Rc in 40% to 50% by weight of the total ginsenosides, preferably 48% by weight; Rb1 in 12% to 17% by weight of the total ginsenosides, preferably 16% by weight; Rb2 in 2% to 5% by weight of the total ginsenosides, preferably 4% by weight; and / or Rd in 12% to 15% by weight of the total ginsenosides, preferably 14% by weight of the total ginsenosides.

[0129] Furthermore, to avoid misunderstanding, Panax quinquefolius (AG) extract may also be in the form of a composition (e.g., a pharmaceutical composition, a dietary supplement, or a food composition) as described herein.

[0130] In special embodiments of the use or methods of the invention described herein, compositions comprising the ginsenoside of the present invention, extracts or compositions comprising the ginsenoside or AG extract of the present invention are administered in amounts ranging from about 100 mg / day to about 2000 mg / day, or from about 500 mg / day to about 1500 mg / day, or from about 200 to about 1000 mg / day. In preferred embodiments, amounts range from about 100 mg / day to 600 mg / day, from about 100 mg to about 400 mg, 200 mg / day, and so on. In any case, a practitioner or other person skilled in the art will be able to routinely determine the actual dosage, and it will be most suitable for the individual patient. The above dosages are illustrative examples for the average case; of course, there may be individual examples of higher or lower dosage ranges, but it is within the scope of the present invention.

[0131] A composition comprising the ginsenoside or Panax quinquefolius extract of the present invention, or a composition comprising the said composition comprising the ginsenoside or AG extract of the present invention, may provide ginsenoside in amounts ranging from about 0.11 to about 10 mg / kg of body weight, from 2.5 to about 6 mg / kg of body weight, or about 3 mg / kg.

[0132] In preferred embodiments, compositions comprising the ginsenoside or Panax quinquefolius extract or composition of the present invention (e.g., pharmaceuticals, dietary supplements, or food compositions) are administered over a long period of time. Typically, the duration of administration of a composition comprising the ginsenoside or AG extract of the present invention, or a composition comprising the ginsenoside or AG extract of the present invention, as used herein, is more than 2 days, more than 3 days, more than 4 days, more than 5 days, more than 6 days, more than 7 days; more than 1 week, more than 2 weeks, more than 3 weeks, more than 4 weeks, more than 5 weeks, more than 6 weeks, more than 7 weeks, more than 8 weeks, more than 9 weeks, more than 10 weeks, more than 1 month, more than 1 month, more than 2 months, more than 3 months, more than 4 months, more than 5 months, more than 6 months, more than 7 months, more than 8 months, more than 9 months, more than 10 months, more than 11 months, or more than 12 months. As used herein, the terms “subject” and “patient” may be used interchangeably and may include mammalian species (in particular humans).

[0133] "Mammals" include, but are not limited to, mice, rats, rabbits, dogs, cats, pigs, and non-human primates, as well as monkeys and chimpanzees, and refer to humans or non-human animals.

[0134] As used herein, the term “therapeutic dose” may refer to an amount of the extract of the present invention or a composition comprising the Panax quinquefolius extract of the invention that imparts a therapeutic effect to a patient (for example, an amount sufficient to treat or prevent fatigue). The effect may be objective (i.e., measurable by several tests or markers) or subjective (i.e., the subject exhibits symptoms or feels an effect).

[0135] When used herein, the terms “treatment” (and similarly, “to treat”) have their ordinary meanings in the field of medicine. In particular, the terms may refer to achieving a reduction in the severity of one or more clinical symptoms associated with a disease or disorder (e.g., fatigue), as this may be determined using techniques known to those skilled in the art (e.g., by a physician) and / or to slow the progression of a disease or disorder (i.e., increasing the amount of time taken for the disease or disorder to progress to a more severe state compared to, for example, the time taken in a poorly treated patient). When used herein, the terms “protection” (and similarly, “protection”) include references to the prevention of a disease or disorder (and vice versa). In particular, the terms may refer to achieving a reduction in the potential of a patient (or healthy subject) progressing the condition (e.g., a reduction of at least 10%, at least 20%, 30%, or 40%, for example, a reduction of at least 50%).

[0136] To avoid misunderstanding, in the context of this invention, the terms “treatment” and “protection” include treating or alleviating, treating, and / or diagnosing patients who require such treatment or treatment, as well as taking preventive measures for sensitive patients, related disease conditions, and / or diagnosing them.

[0137] When used herein in relation to a medical condition, the term “reduce” may mean making an observed amount less, or reducing in size (i.e., reducing fatigue in an object).

[0138] "Administration" or "administering" refers to a route through which a compound or composition provided herein is introduced into an individual in order to perform its intended function. Examples of possible routes of administration include, but are not limited to, oral and parenteral administration (e.g.), such as subcutaneous, intravenous, intramuscular injection, or infusion.

[0139] "Improvement" or "making improvements" means improving or reducing at least one indicator, sign, or symptom of the disease, disorder, or condition associated with the disease. In some embodiments, improvement includes delaying or slowing the progression or severity of one or more indicators of the condition or disease. The progression or severity of an indicator may be determined by subjective or objective measurements, which are known to those skilled in the art. A "healthy subject" refers to an individual who is not known to suffer from any serious disease and who represents a typical population. [Brief explanation of the drawing]

[0140] [Figure 1] Figure 1 shows the research design of the Cereboost long-term study. [Figure 2A] Figure 2A shows that after 4 and 6 hours, Cereboost improves the rate of correct responses compared to placebo. [Figure 2B] Figure 2B shows that after 2 hours, Cereboost improves response time compared to placebo. [Figure 3A]Figure 3A shows that after 2, 4, and 6 hours, Cereboost improves the rate of correct responses compared to placebo. [Figure 3B] Figure 3B shows that Cereboost improves response time compared to placebo after 2, 4, and 6 hours. [Figure 4] Figure 4 shows that after 4 hours, Cereboost improves the rate of correct responses compared to placebo. [Figure 5] Figure 5 shows that after 4 hours, Cereboost improves response time compared to placebo. Figure 6. [Figure 6A] 6A shows that after 6 hours, Cereboost for Emergency 2 improves the rate of correct responses compared to placebo and compared to Emergency 1. [Figure 6B] 6B shows that after 4 hours, Cereboost for Emergency 2 improves response time compared to placebo and compared to Emergency. [Figure 7] Figure 7 shows that long-term Cereboost intake improves the rate of correct responses compared to placebo. [Figure 8] Figure 8 shows that long-term Cereboost intake limits the number of errors compared to placebo. [Figure 9] Figures 9a, b, and c show that long-term Cereboost intake reduces pre-existing fatigue during and after a series of cognitively demanding tasks. [Figure 10] Figure 10 shows that long-term Cereboost intake increases confidence. [Figure 11] Figure 11 shows that long-term Cereboost intake increases vitality.

[0141] example Research design The objective of the experiment was to evaluate the effects of taking 200 mg of a ginseng extract called Cereboost on attention / agility and mood in healthy adults (n=60). Mood was defined as how participants felt at specific times: energized, confident, sad, hostile, and shy.

[0142] The American ginseng extract (Cereboost) used in this study has a total ginsenoside content of approximately 10% to 12% (HPLC). The specific ginsenoside concentrations by weight of the extract are: Rg1 0.1 to 0.4%, R2 0.4 to 3.5%, Rf undetectable, Rb1 0.4 to 7%, Rc 0.5 to 3.5%, Rb2 0.2 to 1.5%, and Rd 0.9 to 3%. The extract is quintozen-free and has a particle size of <250 micrometers. The research design is shown in Figure 1.

[0143] Following mobilization for the study, participants (N=60) began a one-week "acclimatization" phase where they attended the laboratory for the first "execution" session of a cognitive work sequence, having completed a food frequency questionnaire and been given means of habitual eating. They then attended the laboratory for two further test days over a two-week period. On the first test day (Emergency 1, baseline), participants arrived in the laboratory fasted, having received a standard breakfast and followed a cognitive and mood work sequence. Participants were then administered their assigned intervention and retested at two-hour intervals over a six-hour work sequence (Emergency 1, outcome vs. baseline). Before leaving the laboratory, participants were given enough capsules to consume one capsule / day of their assigned intervention with breakfast for the next 13 days.

[0144] Two weeks after the intervention, subjects were returned to the laboratory, and the procedure for Day 1 of the study was repeated—a baseline test session to assess the cognitive effects of the 14-day intervention (baseline scores for long-term outcomes versus baseline emergency 1 and emergency 2), followed by administration of the final dose of their assigned intervention, and test sessions at 2, 4, and 6 hours post-administration to assess the effects of tolerance (emergency 2, outcome versus baseline 2). For all test sessions, a computerized series of tests was used to assess cognitive function and mood effects. The work included:

[0145] 1)Positive and Negative Affect schedule Now(PANAS-NOW): The Positive and Negative Affect Scale (PANAS-N) will be used to investigate mood states at the beginning and end of a series of cognitive tasks.

[0146] It is considered a reliable tool for nonclinical populations (Crawford, JR, & Henry, JD (2004). The Positive and Negative Affect Schedule (PANAS): Construct validity, measurement properties and normative data in a large non-clinical sample. British journal of clinical psychology, 43(3), 245-265.). Participants were asked to rate the degree to which they experienced each of 20 emotions on a 5-point Likert scale ranging from "very slightly" to "very much." Half of the emotion words presented were related to negative emotions (suffered, upset, guilty, embarrassed, hostile, irritable, nervous, anxious, scared, frightened), and the other half were related to positive emotions (interested, attentive, caring, excited, enthusiastic, motivated, proud, resolute, strong, energetic). PANAS-X would be used to measure characteristic moods. In addition, fatigue levels 1 and 2 will be assessed before and after the cognitive session using a visual analog scale ranging from 1 to 9.

[0147] 2) Immediate and delayed word memory, Using the methodology outlined in Scholey et al., (2010) (Scholey, A., Ossoukhova, A., Owen, L., Ibarra, A., Pipingas, A., He, K., ... & Stough, C. (2010). Effects of American ginseng (Panax quinquefolius) on neurocognitive function: an acute, randomised, double-blind, placebo-controlled, crossover study. Psychopharmacology, 212(3), 345-356.), participants will be presented with a continuous list of 15 words at a rate of one word per second.

[0148] Next, participants will be given 60 seconds to input as many words as possible, along with a score recorded as a percentage of the resulting accuracy. Approximately 35 minutes after the immediate word memorization task, participants will be allowed another 60 seconds to record as many items as they can remember from the immediate word memorization test.

[0149] 3) Corsiblocks task, This exercise investigates visual-spatial memory. Nine identical squares are fixed in a random arrangement on a screen. Participants are asked to observe the spatial arrangement between blocks of 2 and 9. During the exercise, four versions of each arrangement length are presented. The exercise involves recreating the arrangement immediately after each presentation by pressing the relevant squares on the screen. The dependent variable is the number of blocks pointed to in the correct order. A new arrangement will be presented each time, and its order will be balanced across all participants.

[0150] 4) Rapid Visual Information Processing task (RVIP); This task will assess attention processing. In this task, a series of digits will be presented on the screen one by one at a rate of 100 per minute without interruption. Participants must investigate sequences of digits consisting of three consecutive even or three consecutive odd digits. Participants must respond by pressing the spacebar as quickly as possible once they detect the sequence string. Up to eight correct target strings will be presented every minute, and the task will last approximately six minutes. The task will be scored for accuracy.

[0151] 5) Modified attention network task (MANT), This task investigates executive function, attention, and inhibition. In this task, participants must respond to a centrally presented arrow by indicating left or right by pressing the corresponding key on the keyboard. The central arrow is adjacent to arrows pointing in the same (matching) or opposite (mismatching) direction.

[0152] To effectively perform the task, participants must ignore adjacent arrows. Previous research had found that participants exhibited greater potential and more errors on mismatched attempts compared to congruent attempts, due to the conflicting interference of opposing arrows as mismatches. The response potential to congruent attempts reflects the processing speed, while the amount of interference between mismatched attempts indicates sensitivity to interference.

[0153] 6) Task Switch task (TST). This task measures executive function and attention. Participants view eight equally spaced circles with radii, two of which form a bold bifurcating line. Numbers are randomly selected from pairs of 1-4 and 6-9 and presented sequentially in a clockwise direction. Responses higher or lower than 5 are made for attempts below the bold line, and even or odd responses are made for numbers above the line. General measures of accuracy and response time are obtained, along with specific measures of switching sacrifices for the first attempt after each task change. Data were analyzed using Linear Mixed Modelling for each outcome variable, along with post-hoc analysis, and several primary or mutual effects between variables were further investigated. Using the design outlined above, the following three comparisons are available:

[0154] 1) Assessment of the immediate effect of the Cereboost treatment by comparing baseline results on day 1 of the trial with results at 2, 4, and 6 hours after the treatment (session 1 vs. sessions 2, 3, and 4);

[0155] 2) Assessment of the urgent effect of Cereboost treatment after a long-term treatment period, comparing baseline results on day 14 of the trial with results at 2, 4, and 6 hours post-treatment (session 5 vs. sessions 6, 7, and 8);

[0156] 3) Evaluation of improvement between emergency 1 and emergency 2, comparing the results of emergency 1 to emergency 2, comparing the results of emergency 1 to emergency 2 in the days following no treatment or prolonged treatment (session 2 to session 6; session 3 to session 7; session 4 to session 8);

[0157] 4) Evaluation of the effect of repeated Cereboost treatment by comparing baseline performance on day 1 of the trial with baseline performance on day 14 of the trial (i.e., 2 weeks after daily treatment: (1 session vs. 5 sessions)).

[0158] result 1- Results of Emergency 1 : MANT task: Cereboost demonstrated an increase in the percentage of correct responses and improved response times in MANT (Figures 2a and 2b). In general, participants who received Cereboost responded faster and more accurately, demonstrating higher attention and agility compared to those who received placebo.

[0159] 2- Results of Emergency 2 : MANT task: Cereboost demonstrated an increase in the percentage of correct responses and improved response times in MANT (Figures 3a and 3b). In general, participants who received Cereboost responded faster and more accurately, demonstrating higher attention and agility compared to those who received placebo.

[0160] CORSItask: Cereboost demonstrated an increased rate of correct responses in the CORSItask (Figure 4). Overall, participants who received Cereboost responded more accurately and demonstrated higher attention and agility compared to those who received placebo. Interestingly, the 4h period corresponds to postprandial hypoglycemia observed in the placebo group, not after Cereboost intake. Switch task: Cereboost demonstrated an increase in response time in the Switch task (Figure 5). In general, participants who received Cereboost demonstrated faster response times and higher attention and agility compared to those who received placebo.

[0161] 3- Results of Emergency 1 vs. Emergency 2 : MANT task: From Emergency 1 to Emergency 2, Cereboost demonstrated an increased rate of correct responses and improved response times in MANT (Figures 6a and 6b). In general, participants who received Cereboost responded faster and more accurately, demonstrating higher attention and agility compared to those who received placebo. These improvements were amplified by a 14-day Cereboost pretreatment, which helped improve cognitive performance. 4- Long-term results : MANT task: Long-term Cereboost intake was shown to increase the rate of correct responses in the MANT task (Figure 7). In general, participants who received Cereboost demonstrated more accurate responses and higher attention and agility over the long term compared to those who received placebo.

[0162] RVIPtask: Long-term Cereboost intake was shown to limit the number of errors in the RVIP task (Figure 8). In general, participants who received Cereboost demonstrated more accurate responses and higher attention and agility over the long term compared to those who received placebo.

[0163] Fatigue 1 and 2 / PANAS-X Fatigue tasks: Long-term Cereboost intake was shown to limit fatigue before (Fatigue 1: Figure 9a), during (PANAS-X Fatigue, sensory and emotional: measures such as sleepy, tired, dull, drowsy, etc., Figure 9b), and after (Fatigue 2: Figure 9C). Generally, participants who took Cereboost over an extended period felt more energized compared to those who took placebo.

[0164] PANAS-X Self-assurance task: Long-term Cereboost intake was shown to increase self-confidence by reorganizing sensations and emotions such as proud, strong, confident, bold, fearless, and courageous within PANAS-X (Figure 10). Generally, due to the increase in self-confidence, participants who took Cereboost over the long term felt more confident and definitive.

[0165] PANAS-X Joviality task: Long-term Cereboost intake was shown to increase joviality by reorganizing sensory and emotional states such as cheerful, happy, joyful, happy, enthusiastic, motivated, active, and energetic within PANAS-X (Figure 11). Generally, participants who took Cereboost over an extended period reported feeling more pleased.

Claims

1. A composition comprising Panax quinquefolius extract for use in treating, reducing, preventing, and / or improving fatigue in a healthy subject, The extract contains ginsenosides at a rate of approximately 9% to 15% by weight, and the extract is as follows: Rg1, which accounts for approximately 1% to 4% of the total ginsenosides by weight. Re accounts for approximately 4% to 35% of the total ginsenosides by weight. Rb1 accounts for approximately 40% to 70% of the total ginsenosides by weight. Rc accounts for approximately 5% to 35% of the total ginsenosides by weight. Rb2 accounts for approximately 2% to 15% of total ginsenosides by weight. Rd account for approximately 9% to 30% of total ginsenosides by weight. The composition comprising the above.

2. A composition comprising a ginsenoside for use in treating, reducing, preventing, and / or improving fatigue in healthy subjects, The composition contains approximately 9% to 15% by weight of ginsenosides, and the composition is as follows: Rg1, which accounts for approximately 1% to 4% of the total ginsenosides by weight. Re accounts for approximately 4% to 35% of the total ginsenosides by weight. Rb1 accounts for approximately 40% to 70% of the total ginsenosides by weight. Rc accounts for approximately 5% to 35% of the total ginsenosides by weight. Rb2 accounts for approximately 2% to 15% of total ginsenosides by weight. Rd account for approximately 9% to 30% of total ginsenosides by weight. The composition comprising the above.

3. The composition according to claim 2, wherein the ginsenoside is obtained from Panax quinquefolius.

4. The composition according to any one of claims 1 to 3, wherein the composition is administered over a long period of time.

5. A composition according to any one of claims 1 to 4, which treats, reduces, protects against, and / or improves fatigue by treating, reducing, protects against, and / or improves sleepiness, tiredness, dullness, and / or drowsiness.

6. The composition according to any one of claims 1 to 5, administered in the following form: (a) A pharmaceutical or nutritional supplement composition comprising one or more of the compositions described in any one of claims 1 to 5, and optionally a pharmaceutically / nutritionally acceptable additive; or (b) A food composition comprising one or more of the compositions described in any one of claims 1 to 5, and optionally a food-safe component.

7. The composition according to claim 6, wherein the composition is for oral administration.

8. The composition according to any one of claims 1 to 7, wherein the composition is administered in an amount ranging from about 100 mg / day to about 2000 mg / day.

9. The composition according to any one of claims 1 to 8, wherein the administration of the composition is for a period of more than two days.

10. The composition according to any one of claims 1 to 9, wherein the subject is a human.

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