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Trial record 43 of 588 for:    reduced glutathione

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

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ClinicalTrials.gov Identifier: NCT01550432
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Christopher Gardner, Stanford University

Tracking Information
First Submitted Date  ICMJE June 27, 2011
First Posted Date  ICMJE March 12, 2012
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE June 2011
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
Inflammatory Markers [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01550432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2012)
  • Oxidized LDL [ Time Frame: 8 weeks ]
  • Insulin Sensitivity [ Time Frame: 8 weeks ]
  • Weight [ Time Frame: 8 weeks ]
  • Blood pressure [ Time Frame: 8 weeks ]
  • Serum lipids [ Time Frame: 8 weeks ]
  • Insulin [ Time Frame: 8 weeks ]
  • Glucose [ Time Frame: 8 weeks ]
  • Plasma Glutathione levels [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation
Official Title  ICMJE Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Hyperlipidemia
  • Insulin Resistance
  • Hypertension
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 7, 2012)
78
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2012)
90
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550432
Other Study ID Numbers  ICMJE SU-03252010-5442
R21AT004475 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Christopher Gardner, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Christopher D Gardner Stanford University
PRS Account Stanford University
Verification Date May 2017

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