Lyophilizate from cornelian cherry ( cornus mas l.) fruit for use in the prevention of hypoxia

Abstract

The subject of the invention is a lyophilizate from cornelian cherry (Cornus mas L.) fruit for use in the prevention of oxygen deprivation - hypoxia - in tissues. The solution is particularly suitable for people who are physically active.

Description

[0001] Lyophilizate from cornelian cherry (Cornus mas L.) fruit for use in the prevention of hypoxia

[0002] The subject of the invention is a lyophilizate from cornelian cherry (Cornus mas L.) fruit for use in the prevention oxygen deprivation - hypoxia - in tissues. The solution is particularly suitable for people who are physically active.

[0003] Functioning of every internal organ depends on an adequate amount of oxygen, with brain and heart being the most oxygen-dependent organs. During increased physical exertion, oxygen and nutrient demand in tissues increases. In order to supply tissues with adequate amounts thereof, efficient blood flow in the blood vessels is essential. Increasing the blood flow in blood vessels is possible, inter alia, by lowering systemic vascular resistance in the circulatory system. To a large extent, it depends on resting vascular resistance, which determines adequate tissue perfusion during rest and at the onset of physical activity. Hypoxia is a condition in which tissues, organs, or the entire body do not receive enough oxygen to meet their requirements, which reduces and limits the ability of organs to function and therefore leads to reduced ability to undertake and maintain physical activity over time. Oxygen deprivation in tissues has an adverse effect on the entire body, most importantly, it directly negatively affects brain and heart muscle function and may lead to health- and life-threatening conditions, such as myocardial infarction, strokes, and ischemia of other tissues, e.g., retina. Lowering systemic vascular resistance may reduce the risk and limit the effects of organ ischemia, especially of the brain, heart muscle, retina, and skeletal muscles most engaged during physical exertion.

[0004] Lowering systemic vascular resistance preventing hypoxia may also be useful in the treatment of chronic kidney disease (CKD). Lowering systemic vascular resistance may also help in high-altitude adaptation, thereby reducing the risk of and preventing altitude sickness. In addition, it may alleviate the effects of decompression sickness in people who practice deep-sea diving. Lowering systemic vascular resistance may also improve athletic performance in sports that involve significant physical exertion. At the same time, it may reduce the risk of adverse medical consequences of tissue and organ hypoxia in athletes who engage in considerable physical exertion with a significant increase in oxygen demand in tissues, especially in the heart and muscles.

[0005] The prior art discloses a preparation containing an extract from cornelian cherry (Cornus mas L.), variety Raciborski, for maintaining physiological concentration and lowering levels of lipids, particularly triglycerides, and the use of a preparation from the fruit of cornelian cherry (Cornus mas L.), variety Raciborski, for the production of a composition for the prevention and treatment of cardiovascular diseases (PL222598 Bl).

[0006] CN102266452 discloses a traditional Chinese medicine composition that improves tolerance to oxygen deprivation. The active ingredients contained therein are prepared from the following proportions of raw materials: 30-50 parts Rhodiola rosea, 20-40 parts Acorus and 20-30 parts Lycium barbarum, and 10-20 parts Japanese cornelian cherry Cornus officinalis.

[0007] CN108553514 discloses a natural anti-fatigue pharmaceutical composition. The natural pharmaceutical composition with anti-fatigue properties is prepared from a liquid extract of white mulberry - Ramulus mori - and liquid extracts of Japanese cornelian cherry in a ratio of (5-8):(3-4):(2-3).

[0008] CN107259551A discloses a method for preparing a preparation and a preparation being a mixture of herbs increasing hypoxia tolerance, the mixture containing an extract of Japanese cornelian cherry Cornus officinalis.

[0009] The object of the invention is to provide a preparation that lowers systemic vascular resistance (SVR) in physically active individuals and athletes, thereby preventing a state of tissue hypoxia.

[0010] The subject of the invention is a lyophilizate from cornelian cherry (Cornus mas L.) fruit for use in the prevention of tissue hypoxia.

[0011] The cornelian cherry fruit used to produce the lyophilizate come from registered Polish varieties, in particular Raciborski, Bolestraszycki, Szafer, Kresowiak, Podolski, Juliusz, Slowianin, Kotula, Dublany, Florianka, Paczoski, Swietlana varieties, or mixtures thereof.

[0012] Fig. 1 Resting systemic vascular resistance (SVR) values measured in mmHg x s x mL'1in the test group receiving lyophilizate of the cornelian cherry (Cornus mas L.) fruit and in the control group receiving placebo. In the study, all participants received a 4-week supplementation of cornelian cherry and a 4-week supplementation of placebo, interspersed with a 4-week wash out phase. Example

[0013] The study demonstrating the above effect was a randomized, crossover, placebo- controlled, interventional dietary study. The study was completed by 12 adults who were amateur long-distance runners. The subjects were randomly divided into 2 groups.

[0014] In the first phase of the study, subjects in the test group received an oral preparation of cornelian cherry (Cornus mas L.) fruit twice a day in the form of kissel containing 20 g of lyophilizate from cornelian cherry fruit, 20 g of potato flour, and 10 g of sugar. In the second, control group, participants received placebo twice a day in the form of kissel containing 10 g of potato flour, 10 g of sugar, 0.6 g of citric acid, and 0.4 g of Carmina E120 food coloring. The tested preparations were administered for a period of 4 weeks. Subsequently, during the wash out phase, subjects in both groups received no supplementation for 4 weeks. In the second phase of the study, the subjects in the first group, who had previously received cornelean cherry, received placebo for 4 weeks, while the subjects in the second group, who had previously received placebo, received the cornelean cherry fruit preparation for 4 weeks.

[0015] All participants in the first and second phase of the study underwent non-invasive endothelial tests on days 1 and at the end of each phase on day 28, while on days 0 and 29 they underwent a treadmill test with spiroergometry and a transient hypoxia test.

[0016] The diagnostic test in which a decrease in resting systemic vascular resistance was unexpectedly demonstrated was the transient hypoxia test. The study was used to assess the sensitivity of peripheral chemoreceptors using the transient hypoxia method. During the test, the subjects lay on a couch in a supine position, with a silicone mask on their face (model 7450 V2, Hans Rudolph Inc., USA) tightly covering their mouth and nose. The mask was connected to a breathing circuit (a system of tubes and connectors) ensuring unidirectional air flow and opening to the environment. The system allowed for the addition of 100% nitrogen to the inspiratory limb of the breathing circuit. Respiratory parameters were calculated based on inspiratory airflow, recorded using a head placed on the inspiratory limb of the breathing circuit and connected to a digital spirometer (FE141 Spirometer; ADInstruments, New Zealand). The hemodynamic parameter - systemic vascular resistance - was recorded in a continuous and non-invasive manner using a measuring cuff placed on the finger (Human NIBP Nano System INL382, ADinstruments). The ECG recording was carried out using a BioAmp device (ADInstruments). The study conducted on amateur long-distance runners demonstrated that oral administration of lyophilizate from cornelian cherry fruit for 4 weeks, compared with the group receiving placebo, significantly reduced resting systemic vascular resistance measured before the transient hypoxia test (Fig. 1).

[0017] Table 1. Characteristic of the cornelian cherry (Comus mas L.) fruit

[0018] SD - standard deviation

[0019] Table 2. Characteristic of the lyophilizate from the cornelian cherry (Comus mas L.) fruit

[0020] SD - standard deviation

[0021] Table 3. Characteristics of active substances in 20 g of lyophilizate from cornelian cherry (('omits mas L.) fruit contained in one serving of kissel

Claims

Claims1. Lyophilizate from cornelian cherry (Cornus mas L.) fruit for use in the prevention of tissue hypoxia.

Images