Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christopher Gardner, Stanford University
ClinicalTrials.gov Identifier:
NCT01550432
First received: June 27, 2011
Last updated: August 7, 2012
Last verified: August 2012

June 27, 2011
August 7, 2012
June 2011
July 2012   (final data collection date for primary outcome measure)
Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01550432 on ClinicalTrials.gov Archive Site
  • Oxidized LDL [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Insulin Sensitivity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Serum lipids [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Glutathione levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation
Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Obesity
  • Hyperlipidemia
  • Insulin Resistance
  • Hypertension
  • Dietary Supplement: Glutathione
    1,130 mg/day or 2,260 mg/day for 8 weeks
    Other Name: ReadiSorb
  • Dietary Supplement: N-Acetylcysteine
    600 mg/day or 1,200 mg/day for 8 weeks
    Other Name: Twinlab
  • Other: Placebo
    Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day.
    Other Name: Nutrilite
  • Experimental: High-Dose Glutathione
    2,260 mg/day
    Intervention: Dietary Supplement: Glutathione
  • Experimental: Low-Dose Glutathione
    1,130 mg/day
    Intervention: Dietary Supplement: Glutathione
  • Experimental: High-Dose N-Acetylcysteine
    1,200 mg/day
    Intervention: Dietary Supplement: N-Acetylcysteine
  • Experimental: Low-Dose N-Acetylcysteine
    600 mg/day
    Intervention: Dietary Supplement: N-Acetylcysteine
  • Placebo Comparator: Placebo
    Volume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01550432
SU-03252010-5442, R21AT004475
Yes
Christopher Gardner, Stanford University
Stanford University
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Christopher D Gardner Stanford University
Stanford University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP