Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Obesity Clinical Trial

Official title:

Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00994513
• Other study ID #: HAC08-07-02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: October 13, 2009
• Last updated: September 23, 2010
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2010
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Obesity
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Alpha Lipoic Acid
1200 mg/day
• Placebo
1200 mg/day

Locations

Country	Name	City	State
China	Xinjiang Medical University	Urumqi	Xinjiang

Sponsors (2)

Lead Sponsor	Collaborator
Georgia Regents University	Xinjiang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biomarkers of oxidative stress		2 months	No
Primary	Insulin sensitivity		2 months	No
Primary	Endothelial function		2 months	No
Secondary	Inflammatory markers		2 months	No
Secondary	Blood pressure		2 months	No
Secondary	Fasting lipid profile		2 months	No
Secondary	Pulse wave velocity		2 months	No