Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...
Reexamination Certificate
1999-03-12
2001-07-03
Pak, John (Department: 1616)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Having -c-, wherein x is chalcogen, bonded directly to...
C424S195110, C424S600000, C424S630000, C424S638000, C424S641000, C424S643000, C424S702000, C514S002600, C514S007600, C514S012200, C514S023000, C514S052000, C514S054000, C514S168000, C514S249000, C514S400000, C514S419000, C514S423000, C514S458000, C514S494000, C514S499000, C514S500000, C514S546000, C514S547000, C514S549000, C514S552000, C514S556000, C514S558000, C514S561000, C514S562000, C514S564000, C514S565000
Reexamination Certificate
active
06255341
ABSTRACT:
TECHNICAL FIELD
This invention relates to a method to reduce stress induced suppression of the immune system of an animal. The method comprises administering to an animal, prior to, during and/or subsequent to the stress event, a nutritional product comprising a structured glyceride component and an antioxidant system. The invention also relates to a nutritional product that comprises an antioxidant system and a structured glyceride component.
BACKGROUND
Stress is a physical, chemical or emotional factor that causes bodily or mental tension and may be a factor in disease causation. The notion that excessive stress can alter host defenses and increase susceptibility to illness is not new. A publication by Pedersen, et al., provides a review of work conducted in the area of stress and disease. See Pedersen, et al., “The immune system during exposure to extreme physiological conditions”,
Inter J. Sports Med
. 1994 15:5116-5121.
In recent years, rapid advances in the field of immunology have generated intense interest in the interaction between stress induced by psychosocial, nutritional and physical factors and the immune system. A major premise of this work is that stress may enhance vulnerability to disease by exerting an immunosuppressive effect. This may especially be true of diseases intimately connected with immunologic mechanisms such as infection, malignancy and autoimmune disease.
Studies demonstrating immune alterations in human stress encompass a number of models wherein most types of experimental and naturally occurring stresses have been associated with alteration of the components of the immune system. Some of the earliest work was done by the United States National Aeronautic Space Administration (NASA). The NASA studies showed that white blood cells and T-lymphocytes were elevated during the splash-down phase of space flight. However, there was impairment in the lymphoproliferative response to mitogenic stimulation during the first three (3) days after return to earth. A slight decrease in the stimulation response of lymphocytes was also observed prior to launch, possibly due to anticipation. A good overview of stress and immune function can be found in “Stress, Immunity and Illness—A Review”, authored by Dorian and Garfinkel,
Psychological Medicine
, 17:393-407 (1987).
Physical activity and exercise are also known to produce a variety of alterations to the immune system. The effects of vigorous exercise appear to depress immune function and may compromise host defenses against upper respiratory tract infections. Epidemiological studies have generally shown a greater risk of upper respiratory tract infections with vigorous levels of exercise. See Heath, et al., “Exercise and Upper Respiratory Tract Infections”,
Sports Medicine
, 14(6) 353-365 (1992).
As humans age, they experience a decline in most cell mediated and humoral immune responses. The elderly are often stressed from various infections, bereavement, cancer and nutritional deficiencies. The elderly are also often stressed from environmental factors such as inadequate housing and mental deficiencies. Supplementation with modest physiological amounts of micronutrients has been shown to decrease nutritional deficiencies and improve various measures of immunity and decrease the frequency of infection-related illnesses in ninety six (96) elderly subjects (mean age 75). See Chandra R. K., “Effect of Nutrients and Trace Element Supplementation on Immune Responses and Infection in Elderly Subjects;” Lancet 1992, Vol. 340, pp. 1124-1127. The factors of age, exercise, malnutrition and stress have also been investigated by Hoffman-Goetz, L., et al., “Exercise and Immune Function”, CRC Press, Boca Raton (1996).
Infection is characterized by a loss of tissue lipid, protein and micronutrients. This is partially the result of the cytokine mediated response designed to support the activities of the immune system and to protect the host. Grimble in “Malnutrition and the Immune Response”,
Transactions of the Royal Society of Tropical Medicine and Hygiene
(1994) 88, 615-619, reports the influence of protein and amino acid intake on cytokine biology. The author also discusses the modulation of cytokine biology by fat and micronutrient intake.
Blood leukocytes represent only a small portion of the total number of leukocytes in the body, yet they provide an important representation of the state of activation of the immune system. It is known that acute stress induces large, rapid, and reversible changes in the distribution of peripheral blood leukocyte subpopulations. Leukocytes and other subpopulations of lymphocytes were examined by the inventors of this patent application to determine if nutritional supplementation could alter the response of the immune system to stress. The data reported below support the conclusion that the inventive composition is useful in preventing or reducing stress induced suppression of the immune system.
Convincing evidence has been accumulated to show that certain nutrients, particularly vitamins C and E, &bgr;-Carotene and calcium, are useful in the prevention and management of coronary heart disease, hypertension, certain cancers and osteoporosis. In addition, vitamins C, E and &bgr;-Carotene (antioxidant nutrients) seem to offer protection against exercise mediated free radical damage. Thus, it has been suggested that an antioxidant nutrient regimen should be made an integral part of any exercise program directed towards prevention/management of chronic disease and promotion of health. An excellent discussion of antioxidants and physical performance can be found in: (1) “Antioxidants in Infection” by Keuchs,
J. Nutr. Sci. Vitaminol
., S23-S33 (1993); (2) Aruoma, “Free Radicals and Antioxidant Strategies in Sports”,
J. Nutr. Biochem
., 1994, vol. 5, pp. 370-380; and (3) Clarkson, “Antioxidants and Physical Performance”,
Critical Reviews of Food Science and Nutrition
, 35(1&2):131-145 (1995).
A good example of physical and mental stress can be found in the military training exercises utilized by modern armies around the world. The military trainees experience increased incidence of infectious diseases as do populations of humans that are stressed by natural disasters, wartime refugee status and the like. A paper by Bernton, et al., “Adaptation to Chronic Stress in Military Trainees,
Ann NYAcad. Sci
., Vol. 774 (217-231), 1995, reports the findings of studies investigating metabolic, cognitive, endocrinologic and immunologic adaptation in soldiers enrolled at the U.S. Army Ranger School during eight (8) weeks of extremely stressful training. The stress was both physical and emotional.
During the field training, the soldiers were provided only field rations. The ration provided fewer calories than those expended during the field exercise. As the ration provided fewer calories than those expended during the exercise, the soldier was in constant hunger and a progressive weight loss occurred during the exercise. Immune system suppression was evaluated by delayed type hypersensitivity by epicutaneous skin testing to seven (7) antigens. Significant suppression in both the mean number of positive skin tests and total millimeters of skin test induration was noted. Furthermore, it has been found in hospitalized patients that anergy as assessed by delayed type skin hypersensitivity indicates an increased risk of infection and mortality. See Christou NV, et al., “Two techniques of measurement of the delayed hypersensitivity skin test response for the assessment of bacterial host resistance.”
World J. Surg
., 1985;5:798-806 and Christou NV, et al., “The delayed hypersensitivity response and host resistance in surgical patients 20 years later.”
Ann Surg
. 1995;222:534-461. These papers make no suggestion of a nutritional product that would successfully protect a stressed immune system from degradation.
U.S. Pat. No. 4,981,844 to Alexander, et al., discloses a method of improving the immune response in patients comprising the ingestion of a diet that provides 20-60 kilo calories per kg of patient b
DeMichele Stephen J.
McEwen John W.
Wood Steven M.
Abbott Laboratories
Dixon J. Michael
Pak John
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