Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Augusta University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity; Type 2 Diabetes; Cardiovascular Disease

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Alpha Lipoic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00994513

HAC08-07-02

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

ALA

Active Comparator group

Description:

alpha lipoic acid 1200 mg/day

Treatment:

Dietary Supplement: Alpha Lipoic Acid

Placebo

Placebo Comparator group

Description:

placebo 1200 mg/day

Treatment:

Dietary Supplement: Placebo