Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai
Reexamination Certificate
2001-02-14
2004-06-01
Brumback, Brenda (Department: 1654)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Peptide containing doai
C514S023000, C514S161000, C514S277000, C514S356000, C514S419000, C424S195110, C424S725000
Reexamination Certificate
active
06743770
ABSTRACT:
BACKGROUND OF THE INVENTION
Physiologic responses to all stresses are the same; only the intensity of the response and whether or not any given response will be evoked are highly individual. Acute stress, such as that resulting from a trauma, robbery, or loud noise produces a physiologic response that quickly disappears, after which the body returns to its normal, unstressed state. Chronic stress, caused for example by a divorce, an unpleasant boss, or lack of money, is more insidious; the physiologic response endures and the body fails to return to the baseline state. Being in a continuous state of stress makes one feel unwell, partly because the mechanisms that ordinarily help overcome stress become exhausted.
Stress is a state of disharmony which can be corrected by neural pathways, which mediate alertness, cognition and focused attention. A peripheral response occurring simultaneously is the redirection of energy, which allows for oxygen and nutrients to be directed to the central nervous system. Symptoms classically seen in stress occur, such as increases in heart rate, blood pressure, sweating, metabolic rate and peristaltic activity. Thus there is a need for dietary intervention to alleviate stress and symptoms associated therewith.
SUMMARY OF THE INVENTION
The invention relates to a nutritional supplement that can help with the management of stress. The nutritional supplement comprises a low-glycemic-index carbohydrate source, a source of protein, a source of fat, a source of caffeine and a source of 5-hydroxytryptophan (5-HTP). In preferred embodiments, the nutritional supplement comprises, for an about 25 grams to about 100 grams serving, from about 1 to about 100 grams carbohydrate (e.g., one or more low-glycemic-index carbohydrates that may further provide a source of dietary fiber), from about 1 to about 100 grams protein (which includes alpha lactalbumin-enriched whey protein), from about 1 to about 50 grams fat, from about 1 to about 600 mg caffeine and from about 1 mg to about 900 mg 5-HTP. The ranges used herein are based upon a single serving, where two servings are recommended per day. Vitamins and minerals in amounts recommended daily to supplement the diet can also be optionally added.
The nutritional supplement can be made in a variety of forms, such as pharmaceutical compositions (e.g., tablet, powder, suspension, liquid, capsule, gel), nutritional beverages, puddings, confections (i.e., candy), ice cream, frozen confections and novelties, or non-baked, extruded food products such as bars. In another embodiment, the ingredients of the nutritional supplement can be administered separately, such as by incorporating certain components (e.g., bitter tasting ones) into a capsule or tablet and the remaining ingredients are provided as a powder or nutritional bar. The preferred form of the nutritional supplement is a liquid (e.g., nutritional beverage) or a nutritional bar, such as a non-baked, extruded snack bar. The supplement can be formulated for single or multiple daily administration, preferably twice daily, taken as a breakfast replacement and as a mid-afternoon snack to modulate stress and mood which can be impaired by foods consumed at lunch.
The invention further pertains to therapeutic methods for managing stress in individuals in need thereof. The nutritional supplement can be administered to an individual to relieve stress, reduce the risk of chronic conditions of stress, enhance immune function, improve cognitive performance, promote satiety and weight loss, reduce cortisol, increase brain serotonin and improve mood.
DETAILED DESCRIPTION OF THE INVENTION
The invention relates to a nutritional supplement, which contains active ingredients to relieve stress in individuals subjected to stress, particularly chronic stress. The invention assembles clinically proven food-grade nutrients in efficacious doses shown to relieve the symptoms of stress. Specifically, the nutritional supplement comprises low-glycemic-index carbohydrates, protein which includes alpha lactalbumin-enriched protein, fat, caffeine and 5-HTP, in amounts that together work to reduce stress and conditions associated therewith, as discussed below. Carbohydrates from low-glycemic-sources and fiber promote satiety by allowing glucose and insulin to be slowly released into the blood. Increased satiety is beneficial as overeating is a common side effect in stressed individuals. 5-HTP, which is a precursor of serotonin, increases satiety because it increases serotonin production, a hormone which stimulates satiety neurons in the hypothalamus. Caffeine increases mental alertness in a safe and rapid (approximately 30 minutes) manner.
Physiological response to stress is the same regardless of the causation. Under stress, the body releases neurotransmitters (e.g., epinephrine, norepinephrine, serotonin) and cortisol to get the body back to a non-stressed state. In chronic stress, the neurotransmitters can become depleted and as a result, the lack of serotonin is directly related to poor mood and depression. Cortisol, however, does not get depleted and its continued presence in the body depresses mood. Long term exposure to cortisol leads to impaired memory, depressed immune function, central obesity and development of chronic disease. Thus, long term consumption of these ingredients can decrease risk of chronic disease like heart disease and obesity due to long-term exposure to cortisol.
Each serving of the product contains ideally 220 kcal. The protein is preferably alpha lactalbumin-enriched whey protein which is commercially available as PROXIME ALPHA from Borculo Domo Ingredients, Corculo, Netherlands. Alpha lactalbumin-enriched whey protein has been shown to increase serotonin by supplying a rich source of tryptophan, a precursor of serotonin. Stress was shown to be relieved and mood improved within 30 minutes. Cortisol levels were also decreased (Marcus, C. R., et al.,
Am. J. Clin. Nutr.,
71:1536-1544 (2000). Fat is from a non-atherogenic vegetable oil (such as canola, soy, olive), and optionally medium-chain triglycerides, which is oxidized immediately and unable to be stored (Babayan, V. K.,
Lipids,
22:417-20 (1987)).
The nutritional supplement can be made in a variety of forms such as a pharmaceutical composition (e.g., tablet, powder, suspension, liquid, capsule, gel), nutritional beverages, puddings, confections (i.e., candy), ice cream, frozen confections and novelties, or non-baked, extruded food products such as bars, to assist patients with stress management.
The nutritional supplement can be formulated into a snack to be taken as part of the diet or it can be formulated as a meal replacement. For a snack and meal replacement, the nutritional supplement should provide from about 50 to about 400 kcal per serving; from about 100 to about 300 kcal being preferred; and from about 220 kcal being most preferred.
For the purposes of this invention, a preferred nutritional supplement comprises the components described above as a single serving (serving unit), whereby one or a plurality (preferably, two) of these supplement(s) is(are) consumed daily. The proportions of these ingredients are based on an about 60 to about 75 gram serving. The preferred form of administration is a nutritional bar but the supplement could be consumed as a liquid or in tablet form. In a preferred embodiment, each serving (serving size) contains 220 kcal and is comprised of macronutrient percentages in concert with the dietary recommendations of the American Diabetic Association and American Dietary Association. Other serving sizes are contemplated in the invention. The total amount of each ingredient should be appropriately adjusted.
The use levels for ingredients incorporated into the nutritional supplement are illustrated in the chart below and represents broadest, preferred and most preferred embodiments. All ranges are approximate.
Nutrients
Optimal
Recommended
(per serving)
Amount
Preferred Range
Range
Low-glycemic-index
20 g total
10-50 g total
1-100 g total
carbohydrate
Protein
20 g
10-
Bell Stacey J.
Shabert Judith
Brumback Brenda
Functional Foods, Inc.
Hamilton Brook Smith & Reynolds P.C.
Teller Roy
LandOfFree
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