ObesityNCT01550432
Effects of Glutathione (an Antioxidant) and N-Acetylcysteine on Inflammation
A study testing Glutathione and N-Acetylcysteine in people with Obesity and Hyperlipidemia, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hyperlipidemia, Insulin Resistance
- What is being tested?
- Glutathione and N-Acetylcysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
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
- Being tested
- Glutathione, N-Acetylcysteine, Placebo
- Medical subject headings
- Obesity, Hyperlipidemias, Insulin Resistance, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlutathioneDietary supplement
Also called ReadiSorb
1,130 mg/day or 2,260 mg/day for 8 weeks
N-AcetylcysteineDietary supplement
Also called Twinlab
600 mg/day or 1,200 mg/day for 8 weeks
PlaceboOther
Also called Nutrilite
Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Glutathione | Experimental | 2,260 mg/day Receives: Dietary Supplement: Glutathione |
| Low-Dose Glutathione | Experimental | 1,130 mg/day Receives: Dietary Supplement: Glutathione |
| High-Dose N-Acetylcysteine | Experimental | 1,200 mg/day Receives: Dietary Supplement: N-Acetylcysteine |
| Low-Dose N-Acetylcysteine | Experimental | 600 mg/day Receives: Dietary Supplement: N-Acetylcysteine |
| Placebo | Placebo comparator | Volume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Markers
Measured: 8 weeks
Secondary outcomes (8)
Oxidized LDL
Measured: 8 weeks
Insulin Sensitivity
Measured: 8 weeks
Weight
Measured: 8 weeks
Blood pressure
Measured: 8 weeks
Serum lipids
Measured: 8 weeks
Insulin
Measured: 8 weeks
Glucose
Measured: 8 weeks
Plasma Glutathione levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Christopher Gardner, Stanford University
- Investigators
- Christopher D Gardner, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01550432
- Sponsor's protocol ID
- SU-03252010-5442
- Other IDs
- R21AT004475
- Status last verified
- Feb 2023
- First submitted
- 27 Jun 2011
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of GSH and N-Acetylcysteine on Inflammatory Markers Among Adults With CVD Risk
- ClinicalTrials.gov ID
- NCT01550432
- Acronym / sponsor ID
- SU-03252010-5442
- Conditions
- Obesity, Hyperlipidemia, Insulin Resistance, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High-Dose Glutathione | Experimental | Dietary Supplement: Glutathione2,260 mg/day |
| Low-Dose Glutathione | Experimental | Dietary Supplement: Glutathione1,130 mg/day |
| High-Dose N-Acetylcysteine | Experimental | Dietary Supplement: N-Acetylcysteine1,200 mg/day |
| Low-Dose N-Acetylcysteine | Experimental | Dietary Supplement: N-Acetylcysteine600 mg/day |
| Placebo | Placebo comparator | Other: PlaceboVolume of liquid placebo product comparable to glutathione and 1 or 2 placebo pills/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- Daily intake of dietary supplements containing antioxidants or omega-3 FAs
- Fasting blood glucose > 140 mg/dL
- Significant liver enzyme abnormality
- Self reported personal history of:
- Subjects currently receiving the following medications (self report):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlutathioneAlso: ReadiSorb1,130 mg/day or 2,260 mg/day for 8 weeks | Dietary supplement | High-Dose Glutathione, Low-Dose Glutathione |
| N-AcetylcysteineAlso: Twinlab600 mg/day or 1,200 mg/day for 8 weeks | Dietary supplement | High-Dose N-Acetylcysteine, Low-Dose N-Acetylcysteine |
| PlaceboAlso: NutriliteVolume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day. | Other | Placebo |
Primary outcome
Inflammatory Markers
Time frame: 8 weeks
8 secondary outcomes
Oxidized LDL
Time frame: 8 weeks
Insulin Sensitivity
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Serum lipids
Time frame: 8 weeks
Insulin
Time frame: 8 weeks
Glucose
Time frame: 8 weeks
Plasma Glutathione levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher D Gardner principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glutathione and N-Acetylcysteine in people with Obesity and Hyperlipidemia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Markers (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.