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Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

Primary Purpose

Obesity, Cardiovascular Disease, Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Alpha Lipoic Acid
Placebo
Sponsored by
Augusta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Antioxidant, Obesity

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Xinjiang Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ALA

Placebo

Arm Description

alpha lipoic acid 1200 mg/day

placebo 1200 mg/day

Outcomes

Primary Outcome Measures

Biomarkers of oxidative stress
Insulin sensitivity
Endothelial function

Secondary Outcome Measures

Inflammatory markers
Blood pressure
Fasting lipid profile
Pulse wave velocity

Full Information

First Posted
October 13, 2009
Last Updated
September 23, 2010
Sponsor
Augusta University
Collaborators
Xinjiang Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00994513
Brief Title
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Official Title
Effect of Alpha Lipoic Acid on Obesity Related Comorbidities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Augusta University
Collaborators
Xinjiang Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Disease, Type 2 Diabetes
Keywords
Antioxidant, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ALA
Arm Type
Active Comparator
Arm Description
alpha lipoic acid 1200 mg/day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 1200 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Alpha Lipoic Acid
Other Intervention Name(s)
Lipoic acid
Intervention Description
1200 mg/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1200 mg/day
Primary Outcome Measure Information:
Title
Biomarkers of oxidative stress
Time Frame
2 months
Title
Insulin sensitivity
Time Frame
2 months
Title
Endothelial function
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Inflammatory markers
Time Frame
2 months
Title
Blood pressure
Time Frame
2 months
Title
Fasting lipid profile
Time Frame
2 months
Title
Pulse wave velocity
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830054
Country
China

12. IPD Sharing Statement

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Effect of Alpha Lipoic Acid on Obesity Related Comorbidities

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