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

NCT ID: NCT01550432

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

High-Dose Glutathione

2,260 mg/day

Group Type: EXPERIMENTAL

Glutathione

Intervention Type: DIETARY_SUPPLEMENT

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

Low-Dose Glutathione

1,130 mg/day

Group Type: EXPERIMENTAL

Glutathione

Intervention Type: DIETARY_SUPPLEMENT

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

High-Dose N-Acetylcysteine

1,200 mg/day

Group Type: EXPERIMENTAL

N-Acetylcysteine

Intervention Type: DIETARY_SUPPLEMENT

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

Low-Dose N-Acetylcysteine

600 mg/day

Group Type: EXPERIMENTAL

N-Acetylcysteine

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Glutathione

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

Intervention Type: DIETARY_SUPPLEMENT

N-Acetylcysteine

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Other Intervention Names

ReadiSorb; Twinlab; Nutrilite

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Gardner

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher D Gardner

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

R21AT004475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-03252010-5442

Identifier Type: -

Identifier Source: org_study_id