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Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00994513
First Posted: October 14, 2009
Last Update Posted: September 24, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Xinjiang Medical University
Information provided by:
Augusta University
  Purpose
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.

Condition Intervention Phase
Obesity Cardiovascular Disease Type 2 Diabetes Dietary Supplement: Alpha Lipoic Acid Dietary Supplement: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Resource links provided by NLM:


Further study details as provided by Augusta University:

Primary Outcome Measures:
  • Biomarkers of oxidative stress [ Time Frame: 2 months ]
  • Insulin sensitivity [ Time Frame: 2 months ]
  • Endothelial function [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ALA
alpha lipoic acid 1200 mg/day
Dietary Supplement: Alpha Lipoic Acid
1200 mg/day
Other Name: Lipoic acid
Placebo Comparator: Placebo
placebo 1200 mg/day
Dietary Supplement: Placebo
1200 mg/day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994513


Locations
China, Xinjiang
Xinjiang Medical University
Urumqi, Xinjiang, China, 830054
Sponsors and Collaborators
Augusta University
Xinjiang Medical University
  More Information

Responsible Party: Xiaoling Wang, Assistant Professor, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00994513     History of Changes
Other Study ID Numbers: HAC08-07-02
First Submitted: October 13, 2009
First Posted: October 14, 2009
Last Update Posted: September 24, 2010
Last Verified: September 2010

Keywords provided by Augusta University:
Antioxidant
Obesity

Additional relevant MeSH terms:
Obesity
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances