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
  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.


Condition Intervention
Obesity
Hyperlipidemia
Insulin Resistance
Hypertension
Dietary Supplement: Glutathione
Dietary Supplement: N-Acetylcysteine
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Inflammatory Markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 78
Study Start Date: June 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-Dose Glutathione
2,260 mg/day
Dietary Supplement: Glutathione
1,130 mg/day or 2,260 mg/day for 8 weeks
Other Name: ReadiSorb
Experimental: Low-Dose Glutathione
1,130 mg/day
Dietary Supplement: Glutathione
1,130 mg/day or 2,260 mg/day for 8 weeks
Other Name: ReadiSorb
Experimental: High-Dose N-Acetylcysteine
1,200 mg/day
Dietary Supplement: N-Acetylcysteine
600 mg/day or 1,200 mg/day for 8 weeks
Other Name: Twinlab
Experimental: Low-Dose N-Acetylcysteine
600 mg/day
Dietary Supplement: N-Acetylcysteine
600 mg/day or 1,200 mg/day for 8 weeks
Other Name: Twinlab
Placebo Comparator: Placebo
Volume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day.
Other: Placebo
Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day.
Other Name: Nutrilite

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550432

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Christopher D Gardner Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Christopher Gardner, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01550432     History of Changes
Other Study ID Numbers: SU-03252010-5442, R21AT004475
Study First Received: June 27, 2011
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Insulin Resistance
Hyperlipidemias
Vascular Diseases
Cardiovascular Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on September 30, 2014