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

Primary Purpose

Obesity, Hyperlipidemia, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Glutathione

N-Acetylcysteine

Placebo

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

High-Dose Glutathione

Low-Dose Glutathione

High-Dose N-Acetylcysteine

Low-Dose N-Acetylcysteine

Placebo

Arm Description

2,260 mg/day

1,130 mg/day

1,200 mg/day

600 mg/day

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

Outcomes

Primary Outcome Measures

Inflammatory Markers

Secondary Outcome Measures

Oxidized LDL

Insulin Sensitivity

Weight

Blood pressure

Serum lipids

Insulin

Glucose

Plasma Glutathione levels

Full Information

NCT ID

NCT01550432

First Posted

June 27, 2011

Last Updated

February 18, 2023

Sponsor

Stanford University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01550432

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Hyperlipidemia, Insulin Resistance, Hypertension

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-Dose Glutathione

Arm Type

Experimental

Arm Description

2,260 mg/day

Arm Title

Low-Dose Glutathione

Arm Type

Experimental

Arm Description

1,130 mg/day

Arm Title

High-Dose N-Acetylcysteine

Arm Type

Experimental

Arm Description

1,200 mg/day

Arm Title

Low-Dose N-Acetylcysteine

Arm Type

Experimental

Arm Description

600 mg/day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Glutathione

Other Intervention Name(s)

ReadiSorb

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

N-Acetylcysteine

Other Intervention Name(s)

Twinlab

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Other Intervention Name(s)

Nutrilite

Intervention Description

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

Primary Outcome Measure Information:

Title

Inflammatory Markers

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Oxidized LDL

Time Frame

8 weeks

Title

Insulin Sensitivity

Time Frame

8 weeks

Title

Weight

Time Frame

8 weeks

Title

Blood pressure

Time Frame

8 weeks

Title

Serum lipids

Time Frame

8 weeks

Title

Insulin

Time Frame

8 weeks

Title

Glucose

Time Frame

8 weeks

Title

Plasma Glutathione levels

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher D Gardner

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://med.stanford.edu/nutrition/research/completed-studies/antioxidants-and-cvd.html

Description

Study description and summary of results

Learn more about this trial

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

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