Methods for assessing the need for and the effectiveness of therapy with antioxidants

Abstract

The invention relates to diagnostic methods for assessing the need of a subject for treatment with an anti-oxidant, or alternatively, for determining the utilization efficiency and ultimate effectiveness of anti-oxidant therapy in subjects having been treated with antioxidants. More specifically, the methods of the present invention are particularly useful in prophylactic assessment of individuals at risk for developing diseases or conditions in which oxidative stress plays a role, such that an appropriate therapeutic regimen can be prescribed for that individual, thus leading to alternative therapies and/or life style changes. The invention further relates to methods for assessing the need for, the utilization efficiency and the effectiveness of therapy in subjects having received therapy with specific antioxidant and immune enhancing formulations. Kits are also provided for measuring the levels of markers of oxidative stress and immune cell numbers.

1 - 36 . (canceled) 
     
     
         37 . A method for assessing the need for treatment of a subject with an antioxidant comprising the steps of:
 a) collecting a sample of body fluid from a subject suspected of needing such treatment;   b) measuring the amount of lipid peroxide;   c) comparing the amount of lipid peroxide with that of a normal standard; and   wherein the measurement of the levels of lipid peroxide is conducted on a test strip or solid substrate;   wherein the test strip or solid substrate is then analyzed using semi-automated or automated instrumentation;   wherein the presence of lipid peroxide in said sample in amounts that lie outside the normal range are indicative of a need for anti-oxidant treatment.   
     
     
         38 . The method of  claim 37 , wherein the test strip is capable of detecting malondialdehyde (MDA) or thiobarbituric-acid reacting substance (TBARS) as a marker of lipid peroxide. 
     
     
         39 . The method of  claim 37 , wherein the levels of lipid peroxide are measured by Wheeler method, iron thiocyanate method, thiobarbituric acid method or with a combination of a peroxidase and a hydrogen donor 
     
     
         40 . The method of  claim 37 , wherein the lipid peroxide levels are measured with one or more antibodies to metabolites of lipid peroxidases. 
     
     
         41 . The method of  claim 37 , wherein levels of lipid peroxide are measured with an immunological assay. 
     
     
         42 . The method of  claims 37 - 41 , wherein the amount of lipid peroxide in the sample is measured through a colorimetric assay, a fluorescence assay, or a luminometric assay. 
     
     
         43 . The method of  claim 42 , wherein the semi-automated or automated instrumentation is capable of quantifying a colorimetric signal, a fluorescence signal or a luminometric signal on said test strip or solid substrate. 
     
     
         44 . The method of  claim 43 , wherein the semi-automated or automated instrumentation, wherein the semi-automated or automated instrument is further capable of providing a quantitative measurement of lipid peroxides in the sample. 
     
     
         45 . The method of  claim 44 , wherein the lipid peroxide in the sample is measured through a colorimetric assay and the automated or semi-automated instrumentation is capable of providing a quantitative measurement of lipid peroxide in the sample through spectroscopy. 
     
     
         46 . The method of  claim 37 , wherein said subject in need of treatment with an anti-oxidant also experiences a reduction in immune cell number and/or function. 
     
     
         47 . The method of  claim 44 , wherein said immune cell is selected from the group consisting of a T cell, a B cell or a natural killer cell. 
     
     
         48 . The method of  claim 37 , wherein said anti-oxidant comprises a formulation consisting of a glutathione precursor, wherein said glutathione precursor is IMMUNE FORMULATION  100 ™ or IMMUNE FORMULATION 20™. 
     
     
         49 . A method for determining an orally anti-oxidative effective amount of a nutritional or therapeutic composition sufficient to diminish urine lipid peroxide levels, comprising the steps of
 a) collecting a samples of body fluid from a subject prior to administration of the nutritional or therapeutic composition and daily after the start of administration;   b) measuring the amount of lipid peroxide in each sample;   c) comparing the amount of lipid peroxide with that of a normal standard;   d) determining whether lipid peroxide levels of said samples decreases during the course of treatment with said administration of the nutritional or therapeutic composition;   wherein the measurement of the levels of lipid peroxide is conducted on a test strip or solid substrate;   wherein the test strip or solid substrate is then analyzed using semi-automated or automated instrumentation;   wherein orally anti-oxidative effective amount of said administration of the nutritional or therapeutic composition is established when the amount of lipid peroxide in said sample decreases to within the normal range.   
     
     
         50 . The method of  claim 49 , wherein the test strip is capable of detecting malondialdehyde (MDA) or thiobarbituric-acid reacting substance (TBARS) as a marker of lipid peroxide. 
     
     
         51 . The method of  claim 49 , wherein the levels of lipid peroxide are measured by Wheeler method, iron thiocyanate method, thiobarbituric acid method or with a combination of a peroxidase and a hydrogen donor 
     
     
         52 . The method of  claim 49 , wherein the lipid peroxide levels are measured with one or more antibodies to metabolites of lipid peroxidases. 
     
     
         53 . The method of  claim 49 , wherein levels of lipid peroxide are measured with an immunological assay. 
     
     
         54 . The method of  claims 49 - 53 , wherein the amount of lipid peroxide in the sample is measured through a colorimetric assay, a fluorescence assay, or a luminometric assay. 
     
     
         55 . The method of  claim 54 , wherein the semi-automated or automated instrumentation is capable of quantifying a colorimetric signal, a fluorescence signal or a luminometric signal on said test strip or solid substrate. 
     
     
         56 . The method of  claim 55 , wherein the semi-automated or automated instrumentation, wherein the semi-automated or automated instrument is further capable of providing a quantitative measurement of lipid peroxides in the sample. 
     
     
         57 . The method of  claim 56 , wherein the lipid peroxide in the sample is measured through a colorimetric assay and the automated or semi-automated instrumentation is capable of providing a quantitative measurement of lipid peroxide in the sample through spectroscopy. 
     
     
         58 . The method of  claim 49 , wherein said subject in need of treatment with an anti-oxidant also experiences a reduction in immune cell number and/or function. 
     
     
         59 . The method of  claim 49 , wherein said immune cell is selected from the group consisting of a T cell, a B cell or a natural killer cell. 
     
     
         60 . The method of  claim 49 , wherein said anti-oxidant comprises a formulation consisting of a glutathione precursor, wherein said glutathione precursor is IMMUNE FORMULATION 100™or IMMUNE FORMULATION 200™.