Fruit-based composition

Abstract

The present disclosure generally relates to the fruit-based compositions. More particularly, the present disclosure relates to a fruit-based composition comprising camomile extract, magnesium and mulberry leaf extract.

Description

[0001] FRUIT-BASED COMPOSITION

[0002] The present disclosure generally relates to the fruit-based compositions. More particularly, the present disclosure relates to a fruit-based composition comprising the camomile extract, magnesium and the mulberry leaf extract.

[0003] BACKGROUND

[0004] Sleep is a crucial biological function and is considered an important driver of health and well-being across the lifespan. Good sleep quality has been associated with benefits for brain functions, mood and mental performance, cardio-metabolic health, as well as immunity, whilst poor sleep quality can lead to negative consequences for health and wellbeing.

[0005] Sleep quality is strongly associated with cognitive functioning, mood, and feelings of vitality and energy the next day. From a scientific perspective, sleep has been consistently linked with cognitive and mood benefits in humans. Among the different sleep stages, it has been suggested that SWS duration is more closely linked to declarative memory, whereas REM sleep underlies the ability to synthesize abstract information such as detecting patterns in newly acquired information. More recent views on the role of each sleep stage have suggested that SWS and REM might have complementary roles in the consolidation of newly acquired information (for different theories, see Rasch B, Born J. About sleep's role in memory. Physiol Rev. 2013 Apr; 93(2):681-766).

[0006] The majority of evidence on the role of sleep for next-day performance comes from sleep deprivation studies, with evidence suggesting that both sleep disruption and sleep deprivation can negatively impact aspects of cognition, including declarative memory, memory encoding and recall, and cognitive flexibility in using existing information to combine them in novel ways (Matthew P. Walker, The Role of Sleep in Cognition and Emotion, Volume 1156, Issue 1 , The Year in Cognitive Neuroscience, 2009 March, pages 168-197). Among the cognitive domains strongly influenced by sleep, levels of daytime vigilance and subjective alertness are highly correlated with sleep duration . In fact, vigilance tasks have been consistently used as highly sensitive measures of sleep loss. Furthermore, sleep difficulties can have significant negative effects on emotion regulation through a range of mechanisms, including reduced ability to downregulate amygdala activation to negative information. Specifically, studies have found that sleep deprivation can cause an increase of almost 60% in amygdala activity when participants are presented with negative images (Palmer CA, Alfano CA. Sleep and emotion regulation: An organizing, integrative review. Sleep Med Rev. 2017 Feb;31:6-16).

[0007] While the knowledge on direct effect of nutrients on the brain and their mode of action to promote sleep is developed, there are still some scientific gaps on the impact of dietary deficiencies vs. supplementation for sleep quality.

[0008] Thus, there is a need to provide compositions that could be used for the mentioned benefits, such as for improving sleep quality and / or subsequent behavioural or metabolic outcomes.

[0009] SUMMARY

[0010] The inventors identified nutritional solution for consumption to promote sleep quality. Accordingly, the present invention provides a fruit-based composition that could be used for improving sleep quality and / or subsequent behavioural or metabolic outcomes.

[0011] The fruit-based liquid composition contains Camomile extract, preferably in an amount of from about 0.3 to about 0.7 g per 100 ml of liquid composition, and comprises as active ingredient at least:

[0012] Magnesium, preferably in a daily amount of from about 40 to about 250 mg and

[0013] Mulberry leaf extract, preferably in a daily amount of from about 150 to about 400 mg.

[0014] The present invention disclosed herein provides a fruit-based liquid composition that can improve sleep quality by improving nocturnal glycemia during the first hours of sleep (e.g., slow wave sleep (SWS)) which is paramount for promoting the restorative benefits of sleep.

[0015] Additional features and advantages are described in, and will be apparent from, the following Detailed Description.

[0016] DETAILED DESCRIPTION Definitions

[0017] Some definitions are provided hereafter. Nevertheless, definitions may be located in the “Embodiments” section below, and the above header “Definitions” does not mean that such disclosures in the “Embodiments” section are not definitions.

[0018] All percentages are by weight of the total weight of the composition unless expressed otherwise. Similarly, all ratios are by weight unless expressed otherwise. As used herein, “about,” “approximately” and “substantially” are understood to refer to numbers in a range of numerals, for example the range of -10% to +10% of the referenced number, preferably - 5% to +5% of the referenced number, more preferably -1% to +1% of the referenced number, most preferably -0.1% to +0.1% of the referenced number.

[0019] Within the context of the present disclosure, the term “beverage,” “beverage product” and “beverage composition” mean a potable liquid product or composition for ingestion by an individual such as a human and provides water and may also include one or more nutrients and other ingredients safe for human consumption to the individual.

[0020] The terms “serving” or "unit dosage form," as used herein, are interchangeable and refer to physically discrete units suitable as unitary dosages for human and animal subjects, each unit containing a predetermined quantity of the composition comprising an ingredient in an amount sufficient to produce the desired effect, preferably in association with a pharmaceutically acceptable diluent, carrier or vehicle.

[0021] Embodiments

[0022] The present disclosure relates to a fruit-based liquid composition containing Camomile extract, preferably in an amount of from about 0.3 to about 0.7 g per 100 ml of liquid composition, and comprising as active ingredient at least:

[0023] Magnesium, preferably in a daily amount of from about 40 to about 250 mg and Mulberry leaf extract, preferably in a daily amount of from about 150 to about 400 mg.

[0024] In an embodiment, the camomile refers to the flowers of the daisy-like plant of the family Asteraceae. The camomile may be Matricaria recutita (German camomile), Anthemis nobilis (English camomile) or Chamomilum nobile (Roman chamomile). Preferably the camomile is Matricaria recutita. The word camomile is sometimes spelt as chamomile. Camomile contains polyphenols such as apigenin, quercetin, patuletin, and luteolin. Camomile extracts can be prepared by procedures well known in the art. Camomile extracts are also commercially available.

[0025] In an embodiment, Camomile extract is contained in the composition preferably in an amount of about 0.518 g per 100 ml of liquid composition, or in a daily amount of preferably from about 0.155 to about 0.389 g.

[0026] In an embodiment, the composition of the present invention may typically comprise from about 0.01% to about 5%, including from about 0.05% to about 3%, such as from about 0.1% to about 1% of camomile extract by weight of the composition.

[0027] Magnesium may be comprised in the composition in the form of a physiologically acceptable salt and / or via any source comprising magnesium. For example, magnesium carbonate, magnesium chloride, magnesium oxide, magnesium sulphate, magnesium gluconate, magnesium hydroxide, magnesium salts of citric acid, magnesium salts of orthophosphoric acid.

[0028] In an embodiment, magnesium is comprised in the composition preferably in an amount of from about 0.03 to about 1.5 g per 100 ml of liquid composition, more preferably from about 0.062 to about 0.155 g per 100 ml of liquid composition, or in a daily amount of preferably about 46 mg.

[0029] In an embodiment, the composition of the present invention may typically comprise from about 0.01% to about 5%, including from about 0.05% to about 3.5%, such as from about 0.5% to about 2.5% of magnesium by weight of the composition.

[0030] The mulberry extract applicable to the present invention can be of any Morus origin, including, but not limited to, White Mulberry (Morus alba L), Black Mulberry (Morus nigra L.), American Mulberry (Morus celtidifolia Kunth), Red Mulberry (Morus rubra L.), hybrid forms between Morus alba and Morus rubra, Korean Mulberry (Morus australis), Himalayan Mulberry (Morus laevigata), and combinations thereof.

[0031] The starting plant material of mulberry extracts can be fresh, frozen or dried mulberry materials. The extract may be used as a liquid or dried concentrated solid. Research has shown that mulberry plant extracts comprise various physiologically active components including flavonoids, polyphenols, polysaccharides, 1-deoxynojirimycin (DNJ) identified as a-glucosidase inhibitor, fagomine, GABA. 1-deoxynojirimycin (DNJ) is thought to be the main active ingredient acting through potent a-glucosidase inhibition.

[0032] In a preferred embodiment, the mulberry extract (ME) is a mulberry leaf extract (MLE).

[0033] Mulberry extracts can be prepared by procedures well known in the art. Mulberry leaf extracts are also commercially available, such from Karallief Inc, USA, ET-Chem.com, China, Nanjing NutriHerb BioTech Co., Ltd, China, or from Phynova Group Ltd.

[0034] In an embodiment, the Mulberry leaf extract is comprised in the composition preferably in an amount of from about 0.15 to about 1.5 g per 100 ml of liquid composition, more preferably from about 0.333 to about 0.833 g per 100 ml of liquid composition, or preferably in a daily amount of about 250 mg.

[0035] In an embodiment, the composition of the present invention comprises from about 0.01% to about 5%, including from about 0.05% to about 3%, such as from about 0.1% to about 1.5% of Mulberry leaf extract by weight of the composition.

[0036] In an embodiment, the fruit-based liquid composition comprises:

[0037] Camomile extract, preferably in an amount of 0.1-1 wt.% (dry weight),

[0038] Magnesium, preferably in an amount of 0.5-2.5 wt.% and

[0039] Mulberry leaf extract, preferablyin an amount of 0.1-1.5 wt.%.

[0040] In some embodiments, the fruit-based liquid composition is a beverage, a composition based on a fruit(s) extract, juice concentrate, syrup, puree, liquid or a combination thereof.

[0041] In some embodiments, the composition further comprises diluents.

[0042] In some embodiments, the fruit is apple, pear, white grape, red grape, raspberry, blueberry, strawberry, boysenberry, pomegranate, orange, kiwi, watermelon, cantaloupe, honeydew, passion fruit, guava, papaya, mango, banana, pineapple, plum, cherry, tangerine, lemon, lime, apricot or a combination thereof. Any fruit or vegetable base could be used. Preferably the total amount of the camomile extract, magnesium and mulberry leaf extract in the composition is effective to promote better sleep quality to the individual.

[0043] Subsequent behavioural outcomes enhanced by improved sleep quality include one or more of (a) less frequent and / or less severe sleepiness, stress, tension / anxiety, fatigue / inertia or depression / dejection, anger / hostility, subjective frustration and / or (b) more and / or better sleep initiation, relaxation, calmness, alertness, vigor / activity, friendliness, cognition, memory, working memory, attention, vigilance, processing speed, fat utilization, weight management, immunity, subjective perceptions of mental, physical, temporal demands, subjective performance perception or next-day mood.

[0044] In some embodiments, the composition is administered once a day for a total duration of at least 3 days, for at least one week, more preferably for at least two weeks.

[0045] In some embodiments, the composition is a beverage administered to a human adult with sleep complaints. In some embodiments, the composition is administered to a child.

[0046] Preferably, the composition further comprises an ingredient that lowers glycemic response in the individual. Optionally the total amount of the ingredient in the composition and any of the ingredient in the meal is effective to promote better sleep quality for the individual. In some embodiments, the ingredient that lowers glycemic response is one or more of tryptophan (e.g., as a free amino acid and / or in a protein such as whey protein).

[0047] Preferably the composition according to the present invention, is orally administered to the individual in a form selected from the group consisting of a dairy beverage and a non-dairy beverage, and the unit dosage form is a predetermined amount of the beverage.

[0048] In some embodiments, the composition can be a ready to drink (RTD) beverage in a container, and the unit dosage form is a predetermined amount of the RTD beverage sealed in the container, which is opened for the oral administration. An RTD beverage is a liquid that can be orally consumed without addition of any further ingredients. The RTD beverage can be low caloric and / or optionally low volume (e.g., about 10 ml, 30 ml, 50 ml, 75 ml, 100 ml to about 250 ml).

[0049] In other embodiments, the composition is formed by reconstituting a unit dosage form of a powder comprising the ingredient that lowers glycemic response, in water or milk to thereby form the composition subsequently orally administered to the individual (e.g., within about ten minutes after reconstitution, within about five minutes after reconstitution, or within about one minute after reconstitution). The unit dosage form of the powder can be sealed in a sachet or other package, which can be opened for the reconstitution and subsequent oral administration. The beverage reconstituted from the powder can be low caloric and / or low volume (e.g., about 30 ml, 50 ml, 75 ml, 100 ml to about 250 ml).

[0050] The composition can additionally contain excipients, emulsifiers, stabilizers and mixtures thereof. The composition may include any nutritional or non-nutritional ingredient that adds bulk, and in most instances will be substantially inert, and does not significantly negate the blood glucose benefits of the composition. The filler material most typically includes a fiber and / or carbohydrate having a low glycemic index.

[0051] Carbohydrate sources suitable for inclusion in the compositions disclosed herein include those having a low glycemic index, such as fructose and low DE maltodextrins, because such ingredients do not introduce a high glycemic load into the composition. Other suitable components of the composition include any dietary fiber suitable for human or animal use, including soluble and insoluble fiber, especially soluble fibres. Beneficial effects of soluble fibres on glucose response have been widely reported. Non-limiting examples of suitable soluble fibres include FOS, GOS, inulin, resistant maltodextrins, partially hydrolysed guar gum, polydextrose and combinations thereof.

[0052] A non-limiting example of a commercially available fiber for the composition include Sunfiber® (Taiyo International, Inc.,), which is a water-soluble dietary fiber produced by the enzymatic hydrolysis of Guar beans; Fibersol 2™ (Archer Daniels Midland Company), which is a digestion resistant maltodextrin; and polydextrose.

[0053] The composition may further comprise one or more additional components such as minerals; vitamins; salts; or functional additives including, for example, palatants, colorants, emulsifiers, antimicrobial or other preservatives. Non-limiting examples of suitable minerals for the compositions disclosed herein include calcium, phosphorous, potassium, sodium, iron, chloride, boron, copper, zinc, magnesium, manganese, iodine, selenium, chromium, molybdenum, fluoride and any combination thereof. Non-limiting examples of suitable vitamins for the compositions disclosed herein include water-soluble vitamins (such as thiamin (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), pantothenic acid (vitamin B5), pyridoxine (vitamin B6), biotin (vitamin B7), myo-inositol (vitamin B8) folic acid (vitamin B9), cobalamin (vitamin B12), and vitamin C) and fat-soluble vitamins (such as vitamin A, vitamin D, vitamin E, and vitamin K) including salts, esters or derivatives thereof.

[0054] The individual may be a mammal such as a human, canine, feline, equine, caprine, bovine, ovine, porcine, cervine or a primate. Preferably the individual is a human.

[0055] EXAMPLES

[0056] The following non-limiting examples present compositions provided by the present disclosure.

[0057] Example 1

[0058] A fruit-based composition of 30 ml according to the present invention comprises:

[0059] Water 60%

[0060] Camomile exract 0.5 wt.%,

[0061] Magnesium 1.8 wt.%,

[0062] Mulberry leaf extract (Reducose®), 0.8 wt.%

[0063] Blueberry puree 18 wt.%

[0064] Juice concentrate of apple 7 wt.%, pear 5 wt.%, lemon 1 wt.%,

[0065] L-tryptophan 0.6 wt.%,

[0066] Mixed tocopherols 0.02 wt.%

[0067] Vitamin B6 and vitamin B3 0.01 wt.%.

[0068] Example 2

[0069] A fruit-based composition of 75ml according to the present invention comprises:

[0070] Water 67 wt.%

[0071] Camomile exract 0.5 wt.%,

[0072] Magnesium 0.7 wt.%,

[0073] Mulberry leaf extract (Reducose®) 0.3 wt.%

[0074] Blueberry puree 18 wt.%,

[0075] Juice concentrate of apple 7 wt.%, pear 5 wt.%, lemon 1 wt.%,

[0076] L-tryptophan 0.2 wt.%,

[0077] Mixed tocopherols 0.02 wt.%

[0078] Vitamin B6 0.0004 wt.% and vitamin B3 0.004 wt.%. Overall, an improvement in sleep efficiency was observed in the individuals consuming the compositions by faster falling asleep and less wake up time during the night.

[0079] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present subject matter and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.

Claims

CLAIMA fruit-based liquid composition containing Camomile extract, preferably in an amount of from about 0.3 to about 0.7 g per 100 ml of liquid composition, and comprising as active ingredient at least:Magnesium, preferably in a daily amount of from about 40 to about 250 mg and Mulberry leaf extract, preferably in a daily amount of from about 150 to about 400 mg.