WO2015160262A1

WO2015160262A1 - Anti-aging composition

Info

Publication number: WO2015160262A1
Application number: PCT/NO2015/050070
Authority: WO
Inventors: Bjødne ESKELAND
Original assignee: Amerikal Nutraceutical Corp
Current assignee: Amerikal Nutraceutical Corp
Priority date: 2014-04-16
Filing date: 2015-04-16
Publication date: 2015-10-22
Anticipated expiration: 2016-10-16

Abstract

O. no. P61401155PCT00 The present invention relates to a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q10, vitamin K2, fish oil and optionally borage oil; and use of said composition for delaying or slowing down the ageing process; reducing the restitution time needed after heavy physical work out; slowing down the formation of wrinkles in the skin; or in prophylactic and/or therapeutic treatment of a disorder associated with high levels of cortisol.

Description

Anti-aging composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Qi ₀,vitamin K₂,fish oil and optinally borage oil.

FIELD OF THE INVENTION

The present invention relates to a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q10, vitamin K2, fish oil and optionally borage oil; and use of said composition for delaying or slowing down the ageing process;

reducing the restitution time needed after heavy physical work out; slowing down the formation of wrinkles in the skin; or in prophylactic and/or therapeutic treatment of a disorder associated with high levels of Cortisol.

BACKGROUND OF THE INVENTION

Cortisol is a steroid hormone, more specifically a glucocorticoid, produced by the zona fasciculata of the adrenal cortex. It is released in response to stress and a low level of blood glucocorticoid. Its primary functions are to increase blood sugar through gluconeogenesis, suppress the immune system, and aid with fat, protein, and

carbohydrate metabolisms. It also decreases bone formation.

Cortisol is essential for regulating many bodily functions but elevated Cortisol levels over the long term may be associated with a long list of negative effects: blood sugar problems, fat accumulation, compromised immunity, infertility, exhaustion, chronic fatigue, bone loss, high triglyceride levels and heart disease.

Another major negative effect of Cortisol is that it inhibits collagen formation. Collagen is a molecule that makes connective tissue. It's vital for structural support and is found in muscles, tendons and joints, as well as throughout the entire body. During stress the body prioritizes what is important for fight or flight. Wrinkle-free young looking skin is not one of those priorities.

When Cortisol is high, there is also a drop in the production of the anti-aging hormone known as dehydroepiandrosterone (DHEA). The levels of DHEA are naturally high in young people but typically declines after the age of 20. Low levels of DHEA is typically associated with loss of muscle mass, strength, and stamina; low sex drive and sleep problems; fatigue, memory decline, and more.

Thus, there is a need in the art for a composition which may reduce Cortisol levels. SUMMARY OF THE INVENTION

One aspect of the present invention relates to a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q₁₀, vitamin K₂, fish oil and optionally borage oil.

In one embodiment according to the first aaspect of the present invention, said fertilized shell egg is dried fertilized incubated shell egg, the incubation period being 2 to 15 days.

In another embodiment according to the first aaspect of the present invention said shark cartilage is prepared by mincing raw material shark cartilage, subjecting the minced shark cartilage to vacuum drying and then pulverizing the vacuum dried shark cartilage.

In another embodiment according to the first aspect of the present invention said pea protein extract is prepared by grinding raw material peas, subjecting the grinded peas to a separation step wherein a protein fraction is separated from fibers and starch, subjecting the protein fraction to a dewatering step and then subjecting the dewatered protein fraction to a drying step; said separation step preferably involving steam distillation and water extraction.

In another embodiment according to the first aaspect of the present invention said pea protein extract is green pea protein extract.

In another embodiment according to the first aaspect of the present invention said fish oil has a totox value below 25 and an EPA+DHA content above 50 % by weight of the fish oil.

In another embodiment according to the first aaspect of the present invention the composition further comprises borage oil.

In preferred embodiment according to the first aspect of the present invention, said fertilized shell egg is dried fertilized incubated chicken egg in pulverulent form, the incubation period being 3 to 12 days; said shark cartilage is prepared by mincing raw material shark cartilage, subjecting the minced shark cartilage to vacuum drying for less than 60 degrees centigrade and then pulverizing the vacuum dried shark cartilage; said pea protein extract is prepared by grinding raw material peas, subjecting the grinded peas to a separation step wherein a protein fraction is separated from fibers and starch, subjecting the protein fraction to a dewatering step and then subjecting the dewatered protein fraction to a drying step; and said fish oil having a totox value below 25 and an EPA+DHA content above 50 % by weight of the fish oil.

A second aspect of the present invention relates to a composition according to the first aspect of the present invention for reducing the restitution time needed after heavy physical work out or for slowing down the formation of wrinkles in the skin.

A third aspect of the present invention relates to a composition according to the first aspect of the present invention for use in prophylactic and/or therapeutic treatment of memory disorders, sleeping disorders, low sex drive, fatigue, mood disorders, bone loss, high triglyceride levels, heart disorders and loss of muscle tissue.

In one embodiment according to the third aspect of the present invention a subject to be treated is a woman, a subject who is at least 40 years old, a woman who is at least 40 years old, a subject who is at least 60 years old or a woman who is at least 60 years old.

DETAILED DESCRIPTION OF THE INVENTION

Surprisingly it has been discovered that the levels of Cortisol may be decreased by administration into the gastrointestinal tract of a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q10, vitamin K2, fish oil and preferably borage oil.

As described further below this surprising effect has been proven in clinical trials.

In these trials (example 4) it has been shown that both men and women may have have their Cortisol levels significantly decreased. As shown in example 4, table 1 and table 2, women seemed to have greater lowering effect on their Cortisol level than men and higher initial dosage seemed to be slightly more efficient in affecting the Cortisol level at the end of the study. As it appears from example 4, table 2, the initial high dosage (4 x 2) seems more efficient to lower the Cortisol level than the gradual increase over 12 days. Based on these data it seems that it is preferred to take a high initial dosage and graduallyu reduce to a maintenance dosage. An "hangover effect" on the high dosages into the lower dosages is expected as there were no washout period between the treatments.

Example 4, table 3 and 4 show the Cortisol level in response to age and gender. Women seemed to have greater response to the composition according to the present invention than men and the eldest group seemed to have greater lowering effect on their Cortisol level than the younger groups. Subjects in the lowest age group had no significant differences as to the gender.

Example 5, table 5 shows that both men and women experienced higher quality of sleep, increased feeling of happiness, increased energy levels, improved self esteem and improved mental sharpness in response to the composition according to the present invention.

Thus viewed from one aspect this invention provides a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q10, vitamin K2, fish oil and preferably borat oil.

By a shell egg is meant an animal egg (e.g. bird or reptile egg) having an opaque shell.

Particularly preferably, the eggs used will be avian eggs, especially those from birds bred for egg production, e.g. hens, geese, ducks, quail, turkeys, ostriches, pheasants, pigeons or the like, most especially hens. Most preferably, the eggs used will be chicken eggs.

As shown by the trials reported above, the Cortisol lowering effect occurs with fertilized eggs rather than with unfertilized eggs. Without being bound by theory, it is believed that this is as a result of the production of the active factors in the transformation of the egg yolk during embryogenesis.

In the general production of eggs for human consumption, the eggs used are either unfertilized or majoritively unfertilized, and even if fertilized eggs are (inadvertently) presented for human consumption these will generally be unincubated eggs or eggs which have been incubated only for 1 or 2 days.

The eggs used according to the invention are desirably ones in the blastodermal and subsequent preembryonic to protoembryonic stages in which yolk transformation has begun, but the organs of the embryo are barely if at all discernible; this corresponds essentially to the subembryonic liquid stage of embryogenesis (generally 3 to 14 days incubation for a hen's egg), or the period up to the acceleration of calcium uptake by the embryo (this occurs after about 15 days incubation for the hen's egg).

In the case of fertilized hens eggs used according to the invention, the incubation period is preferably 2 to 15 days especially 3 to 12, particularly 5 to 10, and most preferably 7- 9 days. Eggs incubated for such periods would generally not be considered fit for human consumption due to the degree of transformation of the yolk that has occurred and, for the upper limit due to the presence of an embryo with visible organs.

In one embodiment according to the present invention, the fertilized shell egg is dried. The dried egg may be prepared for example by freeze drying the whole uncooked contents from within the egg shell.

Alternatively however the contents may be divided to remove some or all of the albumin and if desired some or all of the macroscopic structures within and surrounding the yolk (i.e. membranes, blood vessels, embryo etc). Nevertheless for general ease of preparation, either the entire shell content or the yolk fraction of such contents divided physically into yolk and albumin (e.g. by pouring off the albumin) will normally be used to produce the compositions of the invention.

The freeze dried product produced in this way is low in cholesterol and, as long as the surfaces of the eggs are sterilized before removal of the contents there should be no health concerns relating to the ingestion of the product. Nonetheless the eggs should preferably be derived from a salmonella free flock and thus fertilized hens eggs deriving from Norway, Sweden, Finland, New Zealand and Malta are particularly suitable.

In one embodiment according to the present invention the the fertilized shell egg is in pulverulent form, e.g. in the form of a powder. By shark cartilage is meant the tough material that composes a shark's skeleton.

The raw material shark cartilage is supplied by the fishers and preferably washed completed by flowing clean water. The washed shark cartilage is minced and then dried to remove water. Preferably said drying step is vacuum drying. In one preferred embodiment, the minced shark cartilage is subjected to vacuum drying less than 60 degrees centigrade. The product is then typically pulverized and screened.

In one embodiment according to the present invention shark cartilage is prepared by the following steps:

- shark cartilage is preferably soaked in water, more preferably cold water. It is preferred that the shark cartilage is soaked in cold water for a period of 3-8 hours, more preferably for 5-6 hours.

- preferably removing flesh and blood from the shark cartilage;

- washing the shark cartilage with water, preferably clean water;

- sterilizing the shark cartilage, preferably by raising the temperature to 90°C, then cool the shark cartilage to room temperature;

- subjecting shark cartilage to drying treatment, preferably drying at a temperature above 50°C, more preferably at a temperature above 60°C and even more preferably at a temperature around 65C;

- crushing the shark cartilage, preferably to 5- 10mm pieces;

- preferably drying the crushed shark cartilage pieces, preferably for more than 3 hours, even more preferably for more than 3.5 hours and most preferably for about 4 hours and then cooling the shark cartilage to room temperature;

- milling the shark cartilage; and

- optionally filtering the milled shark cartilage.

The pea protein extract may be prepared by grinding raw material peas, subjecting the grinded peas to a separation step wherein a protein fraction is separated from fibers and starch, subjecting the protein fraction to a dewatering step and then subjecting the dewatered protein fraction to a drying step; said separation step preferably involving steam distillation and preferably water extraction.

In one embodiment according to the present invention pea protein extract is be prepared by the following steps:

- dehulling raw material peas; - grinding the dehulled raw material peas;

- separating protein fraction from fibers and starch, preferably by steam distillation and water extraction;

- dewatering the protein fraction;

- drying the dewatered protein fraction; and

- sieving the dried protein fraction.

In one embodiment according to the present invention said pea is green pea.

Coenzyme Qio, also known as ubiquinone, is a 1 ,4-benzoquinone, where Q refers to the quinone chemical group, and 10 refers to the number of isoprenyl chemical subunits in its tail.

Coenzyme Qio

This oil-soluble, vitamin-like substance is present in most eukaryotic cells, primarily in the mitochondria. It is a component of the electron transport chain and participates in aerobic cellular respiration, generating energy in the form of ATP. Most of the human body' s energy is generated this way. Therefore, those organs with the highest energy requirements, such as the heart, liver and kidney, have the highest CoQio

concentrations. There are three redox states of CoQio: fully oxidized (ubiquinone), semiquinone (ubisemiquinone), and fully reduced (ubiquinol). The capacity of this molecule to exist in a completely oxidized form and a completely reduced form enables it to perform its functions in the electron transport chain and as an antioxidant respectively.

In one embodiment according to the present invention, the Coenzyme Qio present in the composition according to the present invention is ubiquinone, semiquinone, ubiquinol or any mixture thereof. Preferably Coenzyme Qio present in the composition according to the present invention is ubiquinone, semiquinone or any mixture thereof and most preferably Coenzyme Qio present in the composition according to the present invention is ubiquinone. The the Coenzyme Q₁₀ present in the composition according to the present invention may be in the form of a complex with other molecules such as coenzyme Q10 - cyclodextrin complex or coenzyme Q10 - β-cyclodextrin complex.

The the Coenzyme Q₁₀ present in the composition according to the present invention is preferably in the form of a powder.

Vitamin K₂ is a group name for a family of related compounds, generally subdivided into short-chain menaquinones (with MK-4 as the most important member) and the long-chain menaquinones, of which MK-7, MK-8 and MK-9 are nutritionally the most recognized.

The number of side chains is indicated in the name of the particular menaquinone (e.g., MK-4 means that four molecular units - called isoprene units - are attached to the carbon tail) and this may influence the transport to different target tissues.

In one embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is selected from the long-chain menaquinones or any mixture thereof.

In one embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is selected from the short-chain menaquinones or any mixture thereof.

In one embodiment according to the present invention, the Vitamin K₂ present composition according to the present invention is a mixture of short-chain

menaquinones and long-chain menaquinones. In one embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is MK-4, MK-5, MK-6, MK-7, MK-8, MK-9, MK-10 or any mixture thereof. In one preferred embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is MK-4, MK-5, MK-6, MK-7, MK-8, MK-9 or any mixture thereof. In a more preferred embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is MK-7, MK-8, MK-9 or any mixture thereof. In the most preferred embodiment according to the present invention, the Vitamin K₂ present in the composition according to the present invention is MK-7.

By fish oil is meant a fish oil or an oil derived from fish oil. An oil derived from fish oil is typically a fish oil that has been subjected to processing steps in order to e.g. increase the concentration of certain compounds or transform triglycerides into free fatty acids and/or ethyl esters.

In one embodiment according to the present invention the content of EPA, DHA, 18:3, 20:4, 21 :5 and 22:5 in said fish oil is higher than 50 % by weight of the fish oil, preferably higher than 55 % by weight of the fish oil, even more preferabley higher than 60 % by weight of the fish oil and most preferably higher than 65 % by weight of the fish oil.

In one embodiment according to the present invention the content of EPA + DHA in said fish oil is higher than 45 % by weight of the fish oil, preferably higher than 50 % by weight of the fish oil and even more preferabley higher than 55 % by weight of the fish oil.

In one embodiment according to the present invention the content of EPA in said fish oil is higher than 20 % by weight of the fish oil, preferably higher than 25 % by weight of the fish oil, even more preferabley higher than 28 % by weight of the fish oil and most preferably higher than 30 % by weight of the fish oil.

In one embodiment according to the present invention the content of DHA in said fish oil is higher than 10 % by weight of the fish oil, preferably higher than 15 % by weight of the fish oil, even more preferabley higher than 18 % by weight of the fish oil and most preferably higher than 20 % by weight of the fish oil. In one embodiment according to the present invention the content of EPA as free fatty acid in said fish oil is higher than 180 mg/g of the fish oil, preferably 220 mg/g of the fish oil, even more preferabley higher than 250 mg/g of the fish oil and most preferably higher than 270 mg/g of the fish oil.

In one embodiment according to the present invention the content of DP A as free fatty acid in said fish oil is higher than 80 mg/g of the fish oil, preferably 120 mg/g of the fish oil, even more preferabley higher than 150 mg/g of the fish oil and most preferably higher than 180 mg/g of the fish oil.

In one embodiment according to the present invention the content of EPA as ethyl ester in said fish oil is higher than 200 mg/g of the fish oil, preferably 250 mg/g of the fish oil, even more preferabley higher than 280 mg/g of the fish oil and most preferably higher than 300 mg/g of the fish oil.

In one embodiment according to the present invention the content of DP A as ethyl ester in said fish oil is higher than 120 mg/g of the fish oil, preferably 150 mg/g of the fish oil, even more preferabley higher than 180 mg/g of the fish oil and most preferably higher than 200 mg/g of the fish oil.

In one embodiment according to the present invention, the acid value of the fish oil is less than 4 mg KOH/g, preferably less than 3.5 mg KOH/g, more preferably less than 3.0 mg KOH/g, even more preferably less than 2.5 mg KOH/g and most preferably less than 2 mg KOH/g.

In one embodiment according to the present invention the peroxide value of the fish oil at time of release is less than 4.0 meq/kg, preferably less than 3.8 meq/kg, more preferably less than 3.5 meq/kg, even more preferably less than 3.2 meq/kg and most preferably less than 3.0 meq/kg.

In one embodiment according to the present invention the anisidine value of the fish oil at time of release is less than 25, preferably less than 22, more preferably less than 20, even more preferably less than 17 and most preferably less than 15. In one embodiment according to the present invention the totox value of the fish oil is less than 30, preferably less than 27, more preferably less than 25, even more preferably less than 22 and most preferably less than 21.

In one embodiment according to the present invention the fish oil contains more than 500 ppm mixed tocopherols, preferably more than 1000 ppm mixed tocopherols, even more preferably more than 1500 ppm mixed tocopherols and most preferably more than 2000 ppm mixed tocopherols.

In one embodiment according to the present invention the fish oil contains mixed tocopherols in the range 500-2500 ppm, preferably in the range 1000-2500 ppm, more preferably in the range 1500-2500 ppm and most preferably in the range 1500-2500 ppm such as about 2000 ppm.

Borage oil is derived from the seeds of the Borago officinalis (borage). The borage oil is desired as source of gamma-linolenic acid (GLA), for which borage is the highest known plant-based source (17-28%). The oil content is between 26-38% and in addition to GLA typically contains the fatty acids palmitic acid (10-11%), stearic acid (3.5- 4.5%), oleic acid (16-20%), linoleic acid (35-38%), eicosenoic acid (3.5-5.5%), erucic acid (1.5-3.5%)), and nervonic acid (1.5%).

In one embodiment according to the present invention, the acid value of the borage oil is less than 2 mg KOH/g, preferably less than 1.5 mg KOH/g, more preferably less than 1 mg KOH/g, even more preferably less than 0.5 mg KOH/g and most preferably less than 0.3 mg KOH/g.

In one embodiment according to the present invention the peroxide value of the borage oil is less than 10 meq/kg, preferably less than 5 meq/kg, more preferably less than 2.5 meq/kg, even more preferably less than 0.5 meq/kg and most preferably less than 0.3 meq/kg.

In one embodiment according to the present invention the content of CI 6:0 in the borage oil is in the range 5-15 % by weight of the borage oil, preferably in the range 7- 15 % by weight of the borage oil, more preferably in the range 9-15 % by weight of the borage oil and most preferably in the range 9-12 % by weight of the borage oil. In one embodiment according to the present invention the content of CI 8:0 in the borage oil is in the range 1-10 % by weight of the borage oil, preferably in the range 2-8 % by weight of the borage oil, more preferably in the range 3-8 % by weight of the borage oil and most preferably in the range 3-5 % by weight of the borage oil.

In one embodiment according to the present invention the content of CI 8: 1 in the borage oil is in the range 3-20 % by weight of the borage oil, preferably in the range 5- 20 % by weight of the borage oil, more preferably in the range 10-20 % by weight of the borage oil and most preferably in the range 15-20 % by weight of the borage oil.

In one embodiment according to the present invention the content of CI 8:2 in the borage oil is in the range 20-42 % by weight of the borage oil, preferably in the range 25-42 % by weight of the borage oil, more preferably in the range 30-42 % by weight of the borage oil and most preferably in the range 35-42 % by weight of the borage oil. In one embodiment according to the present invention the content of CI 8:3 (GLA) in the borage oil is in the range 15-30 % by weight of the borage oil, preferably in the range 15-25 % by weight of the borage oil, more preferably about 20 % by weight of the borage oil.

In one embodiment according to the present invention the content of C20: 1 in the borage oil is in the range 1-10 % by weight of the borage oil, preferably in the range 2-8 % by weight of the borage oil, more preferably in the range 3-8 % by weight of the borage oil and most preferably in the range 3-5 % by weight of the borage oil.

In one embodiment according to the present invention the content of C22: 1 in the borage oil is in the range 1-10 % by weight of the borage oil, preferably in the range 1-8 % by weight of the borage oil, more preferably in the range 1-6 % by weight of the borage oil and most preferably in the range 1-4 % by weight of the borage oil.

As previously discussed, it has been discovered that the levels of Cortisol may be decreased by administration into the gastrointestinal tract of a composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q10, vitamin K2, fish oil and preferably borage oil. This surprising effect has been proven in clinical trials. Thus, a second aspect of the present invention relates to a composition according to the first aspect of the present invention for reducing the restitution time needed after heavy physical work out or for slowing down the formation of wrinkles in the skin.

In one embodiment according to the present invention, the composition according to the present invention is an anti-aging composition.

In one embodiment according to the present invention, the composition according to the present invention is an anti-wrinkle composition.

A third apsect of the present invention relates to a composition according to the first aspect of the present invention for use in prophylactic and/or therapeutic treatment of memory disorders , sleeping disorders, low sex drive, fatigue, mood disorders (use as antidepressant), bone loss, high triglyceride levels, heart disorders and loss of muscle tissue.

In one embodiment according to the third aspect of the present invention said memory disorder is reduced short-term memory. In another embodiment according to the third aspect of the present invention said memory disorder is dementia. In another embodiment according to the third aspect of the present invention said memory disorder is selected from the group consisting of Alzheimer's disease, Pick's disease,

degenerative fronto-temporal dementia, diffuse Lewy body disease, Parkinson's disease, Huntingdon's disease, supranuclear paresis and other rare degenerative diseases, and various forms of vascular dementia.

In one embodiment according to the third aspect of the present invention said sleeping disorders is selected from the group consisting of dyssomnias and narcolepsy.

In one embodiment according to the third aspect of the present invention a subject to be treated is a woman.

In one embodiment according to the third aspect of the present invention a subject to be treated is at least 30 years old, preferably at least 35 years old, more preferably at least 40 years old, even more preferably at least 40 years old such as at least 45, at least 50 or at least 55 years old, most preferably at least 60 years old. In one embodiment according to the third aspect of the present invention a subject to be treated is a woman who is at least 30 years old, preferably at least 35 years old, more preferably at least 40 years old, even more preferably at least 40 years old such as at least 45, at least 50 or at least 55 years old, most preferably at least 60 years old.

A fourth aspect of the present invention relates to a composition according to the first aspect of the present invention for use in prophylactic and/or therapeutic treatment of a disorder associated with high levels of Cortisol.

A fifth aspect of the present invention relates to a composition according to the first aspect of the present invention for delaying or slowing down the ageing process.

The compositions according to the present invention may contain conventional pharmaceutical carriers or excipients and may be presented in standard administration forms for oral or rectal administration, e.g. powders, tablets, coated tablets, capsules, suppositories, etc. Examples of preferred additives include the vitamins and minerals of conventional daily food supplement compositions, sweeteners such as saccharides, carrotenes, folic acid, citrates, add plant flavourings, and in particular ginseng, vitamin B12, vitamin B l (e.g. thiamine), vitamin C, vitamin E (e.g. .alpha. -tocopherol), .beta.- carrotene, folic acid, glucose, fructose, sodium and potassium citrates, magnesium chloride, zinc oxide, and extracts, oils or powders derived from ginseng, aniseed, rosemary, peppermint, hops, camomile, thyme, cloves, and fennel.

The invention will now be described by way of illustration in the following non-limiting examples.

EXAMPLES

Example 1

Preparation of shark cartilage

The raw material shark cartilage is supplied by the fishers and preferably washed completed by flowing clean water. The material is then undergone lyophilization (freeze-dry method). In this process the material is first minced and then vacuum dried less than 60 degrees centigrade. The product is then pulverized and screened. Example 2

Preparation of pea protein extract

The raw material peas are harvested and selected. The extract is removed from the material using steam distillation and water extracting. The extracts are filtered. The product is dried fully. Final QC inspection and packaging completes the process.

Example 3

Experimental composition

An experimental composition comprising:

dried fertilized incubated chicken eggs in the form of a powder, the incubation period being 8 days;

dried shark cartilage in the form of a powder (example 1);

dried green pea protein extract (example 2);

coenzyme Q₁₀- cyclodextrin complex;

vitamin K₂ (MK-7);

fish oil, wherein

the content of EPA is 37.3 % by weight of the fish oil;

the content of DHA is 22 % by weight of the fish oil;

the content of EPA as free fatty acid is 326 mg/g of the fish oil;

the content of DHA as free fatty acid is 198 mg/g of the fish oil;

the content of EPA as ethyl ester is 357 mg/g of the fish oil;

the content of DHA as ethyl ester is 217 mg/g of the fish oil;

acid value is 0.83;

peroxide value is 0.71;

anisidine value is 5.51;

totox value is 6.93; and

the amount of mixed tocopherols is about 2000 ppm;

borage oil, wherein

the acid value is 0.3 mg KOH/g;

peroxide value is 1.7 meq/kg;

the content of C16:0 is 9.5 % by weight of the borage oil;

the content of C18:0 is 4.5 % by weight of the borage oil;

the content of C18: 1 is 18.2 % by weight of the borage oil;

the content of C18:2 is 37.3 % by weight of the borage oil; the content of C18:3 is 20.1 % by weight of the borage oil;

the content of C20: 1 is 4.1 % by weight of the borage oil;

the content of C22: 1 is 2.6 % by weight of the borage oil; and

food additives

was prepared.

Example 4

Experimental composition and its effect on Cortisol levels

The study took place during two periods. The first 16 participants were divided in two groups, eight of them started on high dosage, four capsules twice a day (table 1), the other on low dosage, 1 capsule twice a day (table 2). The same arrangement with the next twelve subjects, where eight started on high initial dosage (table 1) and four on the lower initial dosage (table 2). Each treatment or dosage change took place every fifth days which means each dosage treatment lasted four days. There were no washout treatments between the treatments.

The subjects in this study had no chronic diseases that require drug treatment and none had been on any antidepressant.

As Cortisol has a low molecular weight, is lipophilic of nature, therefore unbound Cortisol enters cells by passive diffusion that make it feasible to measure free Cortisol fraction in any body fluids. In our study Cortisol levels were measured using salivary secret.

Table 1 shows the effect of initial high dosage of the composition according to the invention on Cortisol levels in woman and men.

X = average age Table 2 shows the effect of initial low dosage of the composition according to the invention on Cortisol levels in woman and men.

X = average age

Table 3 shows the Cortisol level in response to age and gender.

Table 4 shows the Cortisol level in response to age and gender.

Example 5

Experimental composition and its effect on criteria associated to general quality of life

18 participants, 10 women and 8 men, age 56-83 were administered four capsules of the experimental composition (example 3) twice a day. Using an analog scale ranging from 0 to 10 the participants were asked to evaluate the effect of the experimental

composition on criteria associated to general quality of life.

Table 5 shows effect on criteria associated to general quality of life

Example 6

Following up study on Cortisol level in elderly subjects

Through previous studies Cortisol has been shown to be a reliable criteria to evaluate the effect of products intended to affect several of the quality of life aspects. Older women seem to respond better, and generally they have higher circulating Cortisol level Cortisol.

10 participants, were divided in three groups, receiving four capsules/day (two capsules twice a day). Group 1 (one female and one male) received the experimental composition (example 3), Group 2 (3 female and one male) received a composition similar to the experimental composition without the fertilized egg extract component. Group 3 (3 female and one male) received a composition similar to the experimental composition without the shark cartilage component Table 6 shows the effect of the composition according to the invention on Cortisol levels in woman and men, compared to reference compositions.

X = average age

Although not statistically significant, the above results are indicative of a more pronounced Cortisol reducing effect of the composition according to the invention compared to reference compositions deficient of one ingredient.

Claims

W e c l a i m 1.

Composition comprising fertilized shell egg, shark cartilage, pea protein extract, coenzyme Q₁₀, vitamin K₂ and fish oil.

2.

Composition according to claim 1, characterized in that said fertilized shell egg is dried fertilized incubated shell egg, the incubation period being 2 to 15 days.

3.

Composition according to claim 1, characterized in that said shark cartilage is prepared by mincing raw material shark cartilage, subjecting the minced shark cartilage to vacuum drying and then pulverizing the vacuum dried shark cartilage.

4.

Composition according to claim 1, characterized in that said pea protein extract is prepared by grinding raw material peas, subjecting the grinded peas to a separation step wherein a protein fraction is separated from fibers and starch, subjecting the protein fraction to a dewatering step and then subjecting the dewatered protein fraction to a drying step; said separation step preferably involving steam distillation and water extraction.

5.

Composition according to claim 1, characterized in that said pea protein extract is green pea protein extract.

6.

Composition according to claim 1, characterized in that said fish oil has a totox value below 25 and an EPA+DHA content above 50 % by weight of the fish oil.

7.

Composition according to claim 1, characterized in that the composition further comprises borage oil.

8.

Composition according to claim 1, characterized in that

- said fertilized shell egg is dried fertilized incubated chicken egg in pulverulent form, the incubation period being 3 to 12 days;

- said shark cartilage is prepared by mincing raw material shark cartilage, subjecting the minced shark cartilage to vacuum drying for less than 60 degrees centigrade and then pulverizing the vacuum dried shark cartilage;

- said pea protein extract is prepared by grinding raw material peas, subjecting the grinded peas to a separation step wherein a protein fraction is separated from fibers and starch, subjecting the protein fraction to a dewatering step and then subjecting the dewatered protein fraction to a drying step; and

- said fish oil having a totox value below 25 and an EPA+DHA content above 50 % by weight of the fish oil.

9.

Composition according to any one of the preceding claims for reducing the restitution time needed after heavy physical work out or for slowing down the formation of wrinkles in the skin.

10.

Composition according to any one of the preceding claims for use in prophylactic and/or therapeutic treatment of memory disorders, sleeping disorders, low sex drive, fatigue, mood disorders, bone loss, high triglyceride levels, heart disorders and loss of muscle tissue.

11.

Composition according to claim 10, wherein a subject to be treated is a woman, a subject who is at least 40 years old, a woman who is at least 40 years old, a subject who is at least 60 years old or a woman who is at least 60 years old.