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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01550432
• Other study ID #: SU-03252010-5442
• Secondary ID: R21AT004475
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: February 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Hypertension
• Insulin Resistance
• Obesity

Intervention

Dietary Supplement:
• Glutathione
1,130 mg/day or 2,260 mg/day for 8 weeks
• N-Acetylcysteine
600 mg/day or 1,200 mg/day for 8 weeks

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Markers		8 weeks
Secondary	Oxidized LDL		8 weeks
Secondary	Insulin Sensitivity		8 weeks
Secondary	Weight		8 weeks
Secondary	Blood pressure		8 weeks
Secondary	Serum lipids		8 weeks
Secondary	Insulin		8 weeks
Secondary	Glucose		8 weeks
Secondary	Plasma Glutathione levels		8 weeks

External Links

•   Study description and summary of results