Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Phase 2
Completed
- Conditions
- ObesityCardiovascular DiseaseType 2 Diabetes
- Interventions
- Dietary Supplement: Alpha Lipoic AcidDietary Supplement: Placebo
- Registration Number
- NCT00994513
- Lead Sponsor
- Augusta University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ALA Alpha Lipoic Acid alpha lipoic acid 1200 mg/day Placebo Placebo placebo 1200 mg/day
- Primary Outcome Measures
Name Time Method Biomarkers of oxidative stress 2 months Insulin sensitivity 2 months Endothelial function 2 months
- Secondary Outcome Measures
Name Time Method Inflammatory markers 2 months Blood pressure 2 months Fasting lipid profile 2 months Pulse wave velocity 2 months
Trial Locations
- Locations (1)
Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China