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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT004475 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The rationale for the potential role of antioxidants in the prevention of cardiovascular diseases (CVD) remains strong despite the disappointing results of recent trials with a few select antioxidant vitamins. Glutathione (GSH) is one of the body's most powerful antioxidant agents but there is a surprising paucity of data on its use as an interventional therapy.
Glutathione, when taken orally, is immediately broken down into its constituent amino acids, of which cysteine is the only one to be essential. Available cysteine is the critical determinant of intracellular GSH concentrations. N-acetyl cysteine (NAC) is an antioxidant supplement that has been used to provide a source of cysteine to replete GSH levels. By replenishing endogenous glutathione, it is possible that NAC would exert the same effect(s) as exogenous GSH.
However, there is a new delivery system, liposomal GSH, which keeps glutathione intact. In this study, the investigators propose to match the cysteine content of NAC and GSH and compare the effects of these two supplements, at two different doses, on markers of inflammation and oxidative stress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Dose Glutathione | Experimental | 2,260 mg/day |
|
| Low-Dose Glutathione | Experimental | 1,130 mg/day |
|
| High-Dose N-Acetylcysteine | Experimental | 1,200 mg/day |
|
| Low-Dose N-Acetylcysteine | Experimental | 600 mg/day |
|
| Placebo | Placebo Comparator | Volume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glutathione | Dietary Supplement | 1,130 mg/day or 2,260 mg/day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Markers | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidized LDL | 8 weeks | |
| Insulin Sensitivity | 8 weeks | |
| Weight |
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Inclusion Criteria:
Gender: Both women and men
Age: > or = 18 years
Ethnicity and race: All ethnic and racial backgrounds welcome
Presence of Metabolic Syndrome: As defined in ATP III of the National 5.Cholesterol Education program, the metabolic syndrome will be diagnosed as presence of at least three of the following, which will be measured at the screening clinic visit:
Central obesity as measured by waist circumference:
Fasting blood triglycerides greater than or equal to 150 mg/dL
Blood HDL cholesterol:
Blood pressure greater than or equal to 130/85 mmHg
Fasting glucose greater than or equal to 100 mg/dL
6.Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation 7.Ability and willingness to give written informed consent 8.No known active psychiatric illness.
Exclusion Criteria:
Daily intake of dietary supplements containing antioxidants or omega-3 FAs
Fasting blood glucose > 140 mg/dL
Significant liver enzyme abnormality
Self reported personal history of:
Subjects currently receiving the following medications (self report):
Body Mass Index (BMI) greater than or equal to 40.
Pregnant or Lactating
Inability to communicate effectively with study personnel
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| Name | Affiliation | Role |
|---|---|---|
| Christopher D Gardner | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006949 | Hyperlipidemias |
| D007333 | Insulin Resistance |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D005978 | Glutathione |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003545 | Cysteine |
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| N-Acetylcysteine | Dietary Supplement | 600 mg/day or 1,200 mg/day for 8 weeks |
|
|
| Placebo | Other | Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day. |
|
|
| 8 weeks |
| Blood pressure | 8 weeks |
| Serum lipids | 8 weeks |
| Insulin | 8 weeks |
| Glucose | 8 weeks |
| Plasma Glutathione levels | 8 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000603 |
| Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |