Cardiovascular Disease, Obesity, Type 2 Diabetes
Conditions
Keywords
Antioxidant, Obesity
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.
Interventions
DIETARY_SUPPLEMENTAlpha Lipoic Acid
1200 mg/day
DIETARY_SUPPLEMENTPlacebo
1200 mg/day
Sponsors
Xinjiang Medical University
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers of oxidative stress | 2 months |
| Insulin sensitivity | 2 months |
| Endothelial function | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory markers | 2 months |
| Pulse wave velocity | 2 months |
| Blood pressure | 2 months |
| Fasting lipid profile | 2 months |
Countries
China
Outcome results
None listed