CompletedNCT00994513Updated Sep 24, 2010

Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

A Phase 2/3 interventional study of Alpha Lipoic Acid and Placebo in Obesity, Cardiovascular Disease and Type 2 Diabetes, sponsored by Augusta University. Completed at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-09-24.

Sponsored by Augusta University · Phase 2/3, Interventional, and Prevention

Phase: Phase 2/3
Study type: Interventional
Enrollment: 70
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study summary

The major objective of this study is to conduct a double-blind, placebo-controlled, randomized clinical trial to assess whether oral alpha lipoic acid supplementation will decrease cardiovascular disease and type 2 diabetes risk in obese subjects.

Conditions studied

Obesity
Cardiovascular Disease
Type 2 Diabetes

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Keywords

Antioxidant
Obesity

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 70 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Augusta University is the lead sponsor of 177 studies on the registry; 24 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Han ethnicity
BMI≥25kg/m2
Having at least one of the following risk factors: borderline hypertension (130mmHg≤SBP\<140mmHg or 85mmHg≤DBP\<90mmHg), dyslipidemia (fasting total cholesterol ≥240mg/dl or HDL-C\<40mg/dl), or impaired fasting glucose (fasting glucose levels between 6.1 and 7.0mmol/L)
18-60 years old
Not on any antioxidant vitamin supplement

Exclusion criteria

Exclusion Criteria:

Pregnancy, lactation or child-bearing age without birth control device
History of hypertension, diabetes, coronary heart disease(CHD), cancer or liver disease
Anything that would impede the subject from complying with the ALA treatment
History of psychiatric problems

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 70 participants (estimated)

Study arms

Active comparator
ALA
alpha lipoic acid 1200 mg/day
Dietary Supplement: Alpha Lipoic Acid
Placebo comparator
Placebo
placebo 1200 mg/day
Dietary Supplement: Placebo

Interventions

Dietary supplementAlpha Lipoic Acid
1200 mg/day
Also known as: Lipoic acid
Dietary supplementPlacebo
1200 mg/day

What researchers measure

Primary outcomes

Biomarkers of oxidative stress
Time frame: 2 months
Insulin sensitivity
Time frame: 2 months
Endothelial function
Time frame: 2 months

Secondary outcomes

Inflammatory markers
Time frame: 2 months
Blood pressure
Time frame: 2 months
Fasting lipid profile
Time frame: 2 months
Pulse wave velocity
Time frame: 2 months

Study locations

1 site

Xinjiang Medical University
Urumqi, Xinjiang 830054, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 24, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00994513
Lead sponsor: Augusta University
Collaborators: Xinjiang Medical University
First posted: Oct 14, 2009
Start date: Jul 2009
Primary completion: May 2010
Completion: May 2010
Last update: Sep 24, 2010

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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