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Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation
Not Recruiting
Trial ID: NCT01550432
Purpose
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.
Official Title
Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
Stanford Investigator(s)
Eligibility
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
Intervention(s):
dietary supplement: Glutathione
dietary supplement: N-Acetylcysteine
other: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Antonella Dewell
6507368577