Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution... – Containing or obtained from leguminosae
Reexamination Certificate
1995-11-01
2004-01-06
Tate, Christopher R. (Department: 1654)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
Containing or obtained from leguminosae
C424S725000, C514S002600, C514S023000, C514S076000, C426S601000, C426S648000, C426S656000, C426S658000, C426S662000
Reexamination Certificate
active
06673378
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to a natural food supplement, phosphatidylserine, to inhibit protein catabolism and promote health and fitness in animals and humans. In particular, this natural, soy derived supplement is preferably used in a regime in which the body is intentionally stressed by dieting or physical exercise. Under such conditions, a program for controlled intake of phosphatidylserine, a constituent in a composition of natural soy phospholipids, suppresses the release of excess cortisol resulting from the physical stress of exercise or dieting.
Optimal health and fitness depends on a combination of diet and exercise. Where the general objective of a health regimen is to achieve physical well-being and avoidance of sickness, a variety of factors must be considered. Typically, health advocates agree that the combination of a balanced diet and moderate exercise is the key to good health. This oversimplification does not account for the wide variations in activity that affect an optimized health regimen.
For example, dieting by restricting food intake without exercise is generally considered unwise. However, if the objective is weight loss without muscle loss, exercise is encouraged and dietary considerations, to maintain necessary dietary minimums, become complex. The body is stressed both by limited food intake and the physical trauma of exercise.
If the objective is increased body strength and muscle mass, the body may encounter extreme physical stress from systematic physical training trauma and a substantially increased food intake. To avoid fatigue and accumulation of fat instead of muscle, the timing and content of food intake relative to the exercise program must be regimentally controlled.
The foregoing two extremes represent the type of induced physical stress for which a programmed regime for use of the dietary supplement, soy derived phosphatidylserine, is directed. In both extremes, the objective is to inhibit protein catabolism and encourage metabolism of dietary and stored carbohydrates and especially body fat for energy.
In U.S. Pat. No. 5,260,219, issued Nov. 9, 1993 to this inventor, entitled, “METHOD OF DETERMINING NITROGEN BALANCE AND FAT LOSS FOR PERSONS INVOLVED IN DIET AND/OR PHYSICAL TRAINING PROGRAM,” a simple system and self test kit for determining urea nitrogen and ketone concentrations in a urine stream was described. The system enabled a user to determine his or her protein nitrogen turnover and body fat metabolism in order to design an effective dietary and exercise program. The teachings of this patent are incorporated herein by reference. The patent teaches the general type of regimen for a weight loss diet or a physical training program that is contemplated for effective use of the phosphatidylserine supplement here described. It is to be understood that the use of phosphatidylserine as a dietary supplement is best used in conjunction with a program or regime involving controlled intake of a protein supplement. Use of a protein supplement, however, is not required. The contemporaneous intake of dietary protein to insure an anabolic state is advantageous for optimum results when taking soy derived, phosphatidylserine supplement.
The basic problem with a haphazard weight loss diet or intermittent strenuous physical activity is the body's response by elevating the level of production of cortisol. Elevated cortisol is an indiscriminate metabolic/catabolic agent that breaks down the body's protein, including muscle tissue, into amino acids which are converted into glucose in the liver. Elevated cortisol is therefore counterproductive in both described situations of diet and exercise where high cost protein is metabolized into cheap sugar fuels. In dieting, desirable muscle is broken down along with stored fat, and in strenuous exercise, hard earned muscle is cannibalized leaving the body weak and exhausted. In both the case of diet and exercise, the induced physical stress results in the triggering of elevated release of adrenal glucocorticoids. Where stress from dieting or exerciser is compounded by physical and/or physiological trauma, the situation is aggravated, causing even higher levels of released cortisol, the principal glucocorticoid that adversely affects the body in elevated levels.
The contributory effect of emotional distress of physical training programs was recognized by Dr. Lewis G. Maharam, in his book,
Maharam's Curve, The Exercise High—How to Get It, How to Keep It
, (W.W. Norton & Co., N.Y. 1992). In a general thesis, Dr. Maharam has correlated the relationship between mood level and effective exercise programs and has devised a useful curve, a truncated sinusoidal with a defined peak, to enable visual programming of the exercise process in conjunction with mood level. The visualized performance curve enables one to manipulate his or her mood level using exercise and following the curve. While cortisol levels were not discussed, the beneficial effect of coordinating mood and exercise using a common sense approach, likely has a corresponding explanation in the level of cortisol release from cumulative non-specific stress.
The devised curve, however, has a universal appeal for defining the concept of strategic event training, where a goal is defined, which may be an athletic contest or the length of a weekend walk, and a definite diet and exercise strategy is devised for peak performance at the time of the event and minimal recovery after the event.
In addition to traditional methods of strategic training, the dietary supplement described herein comprises a powerful tool for optimizing any program of planned diet and exercise.
The intake of appropriate quantities of dietary protein along with non-protein calorie sources, as described in the referenced patent can buffer the destructive effect of elevated cortisol on muscle tissue. Elevated cortisol effectively reduces or blocks amino acid into entry and subsequent conversion to muscle. The use of protein supplements and calorie-dense supplements in above normal quantities permits a change from a catabolic to an anabolic state, minimizing the damaging effect of released cortisol. The ingested protein and carbohydrates are in effect a decoy for the catabolic action of the increased cortisol.
The nutritional supplement, soy derived phosphatidylserine, however, suppresses the release of cortisol under conditions where release would be otherwise increased. This allows available ingested protein to be more available for use by the body in developing muscle and alleviates the antagonistic effect of cortisol on amino acid entry into muscle for the synthesis of new muscle growth.
While the life of primitive man was dominated by brief, intermittent physical stresses, the life of modern man is dominated by chronic mental stress. As a result, our stress arousal system is hopelessly ill-equipped to deal with stress overload, so it overproduces cortisol consistent with a physical exhaustion stage.
For physical stress, the human body is superbly adapted over millions of years for the production of stress hormones. Stress hormones dull pain, redirect energy from nonessential activities, such as digestion or tissue repair, to the specific muscles for fight or flight. But with modern day mental stress, creating a generally elevated background level of cortisol, stress hormones (cortisol) are released in response to physical stress, and are overproduced, and can disrupt digestion, damage the stomach wall, harden arteries, stunt, growth, affect sex life, lower immunity, and promote cancer growth. Excess cortisol has been documented to result in many other physiological and psychological disorders.
Almost any type of physical or mental stress leads to elevated cortisol, which begins by the initial excitation of the hypothalamus. Signals to the hypothalamus come from the hippocampus, limbic system and lower brain stem. After excitation, the hypothalamus produces a corticotrophin releasing factor (CRF). CRF circulates to the pituitary gland where it promotes
Peterson Richard Esty
Tate Christopher R.
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