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

NCT01550432 | Completed

• 2 other identifiers: SU-03252010-5442R21AT004475
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Hyperlipidemia; Insulin Resistance; Hypertension

Outcome Measures

Primary Outcomes (1)

• Inflammatory Markers

  8 weeks

Secondary Outcomes (8)

• Oxidized LDL

  8 weeks

• Insulin Sensitivity

  8 weeks

• Weight

  8 weeks

• Blood pressure

  8 weeks

• Serum lipids

  8 weeks

Study Arms (5)

High-Dose Glutathione

EXPERIMENTAL

2,260 mg/day

Dietary Supplement: Glutathione

Low-Dose Glutathione

EXPERIMENTAL

1,130 mg/day

Dietary Supplement: Glutathione

High-Dose N-Acetylcysteine

EXPERIMENTAL

1,200 mg/day

Dietary Supplement: N-Acetylcysteine

Low-Dose N-Acetylcysteine

EXPERIMENTAL

600 mg/day

Dietary Supplement: N-Acetylcysteine

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Glutathione DIETARY_SUPPLEMENT

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

Also known as: ReadiSorb

High-Dose Glutathione; Low-Dose Glutathione

N-Acetylcysteine DIETARY_SUPPLEMENT

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

Also known as: Twinlab

High-Dose N-Acetylcysteine; Low-Dose N-Acetylcysteine

Placebo OTHER

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

Also known as: Nutrilite

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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):

Sponsors & Collaborators

• Stanford University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Obesity; Hyperlipidemias; Insulin Resistance; Hypertension

Interventions

Glutathione; Acetylcysteine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids

Study Officials

• Christopher D Gardner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 27, 2011
• First Posted: March 12, 2012
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 21, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)