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Not Recruiting
Trial ID: NCT01550432
Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
Inclusion Criteria:
1. Gender: Both women and men
2. Age: > or = 18 years
3. Ethnicity and race: All ethnic and racial backgrounds welcome
4. 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:
- Men: Greater than 40 inches
- Women: Greater than 35 inches
- Fasting blood triglycerides greater than or equal to 150 mg/dL
- Blood HDL cholesterol:
- Men: Less than 40 mg/dL
- Women: Less than 50 mg/dL
- 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:
1. Daily intake of dietary supplements containing antioxidants or omega-3 FAs
2. Fasting blood glucose > 140 mg/dL
3. Significant liver enzyme abnormality
- AST or ALT more than 2 times the upper limit of normal and/or
- Bilirubin more than 50% the upper limit of normal
- Renal disease as measured at baseline:
- Serum creatinine > 1.30 mg/dL, or
- Calculated creatinine clearance < 71 mL/min
4. Self reported personal history of:
- Clotting disorders
- Clinically significant atherosclerosis (e.g., CAD, PAD)
- Malignant neoplasm
- Ongoing infection
- Inflammatory disease (e.g., rheumatoid arthritis)
5. Subjects currently receiving the following medications (self report):
- Anti-Inflammatory drugs
- Lipid lowering drugs including statins
- Anti-hypertensive drugs
- Anti-coagulant drugs
6. Body Mass Index (BMI) greater than or equal to 40.
7. Pregnant or Lactating
8. Inability to communicate effectively with study personnel
dietary supplement: Glutathione
dietary supplement: N-Acetylcysteine
other: Placebo
Not Recruiting
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Antonella Dewell
6507368577