Christopher Gardner
Effects of Glutathione (an antioxidant) and N-Acetylcysteine on Inflammation
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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, we 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.
Stanford Recruiting Status:
RecruitingCondition(s):
Lead Sponsor:
Stanford UniversityIntervention(s):
- Drug: Glutathione or N-Acetylcysteine
Phase:
N/AEligibility
Health of Volunteers:
People with the conditions listed in this trial can not participate as controls.Key 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 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
Planning to be available for clinic visits and bottle pick-ups for the 8 weeks of study participation
Ability and willingness to give written informed consent
No known active psychiatric illness.
Key Exclusion Criteria:
Daily intake of dietary supplements containing antioxidants or omega-3 FAs within the past month.
Fasting blood glucose > 140 mg/dL
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
Self reported personal history of:
Clotting disorders
Clinically significant atherosclerosis (e.g., CAD, PAD)
Malignant neoplasm
Ongoing infection
Inflammatory disease (e.g., rheumatoid arthritis)
Subjects currently receiving the following medications (self report):
Anti-Inflammatory drugs
Lipid lowering drugs including statins
Anti-hypertensive drugs
Anti-coagulant drugs
Body Mass Index (BMI) greater than or equal to 40.
Pregnant or Lactating
Inability to communicate effectively with study personnel
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemalePLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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