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Completed

NCT Number: NCT01550432

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

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.

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Dyslipidemias Glucose Metabolism Disorders Hyperinsulinism Hyperlipidemia Hyperlipidemias Hypertension Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

  • Daily intake of dietary supplements containing antioxidants or omega-3 FAs
  • 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

Treatment and study plan

Glutathione

Dietary Supplement

1,130 mg/day or 2,260 mg/day for 8 weeks

Other names: ReadiSorb

N-acetylcysteine

Dietary Supplement

600 mg/day or 1,200 mg/day for 8 weeks

Other names: Twinlab

Placebo

Other

Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day.

Other names: Nutrilite

Primary outcomes

  1. Inflammatory Markers

    Time frame: 8 weeks

Secondary outcomes

  1. Oxidized LDL

    Time frame: 8 weeks

  2. Insulin Sensitivity

    Time frame: 8 weeks

  3. Weight

    Time frame: 8 weeks

  4. Blood pressure

    Time frame: 8 weeks

  5. Serum lipids

    Time frame: 8 weeks

  6. Insulin

    Time frame: 8 weeks

  7. Glucose

    Time frame: 8 weeks

  8. Plasma Glutathione levels

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 12, 2012
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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