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Lipoic Acid and Prevention of Heart Disease

Sponsor
Oregon State University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00765310
Collaborator
Oregon Health and Science University (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)
100
Enrollment
1
Location
2
Arms
164
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: R-alpha lipoic acid
  • Dietary Supplement: Placebo
 Phase 2/Phase 3

Detailed Description

The purpose of this study is to see if a dietary supplement, R-alpha lipoic acid, is able to reduce risk factors such as body weight and high blood cholesterol levels in overweight or obese participants.

Recruitment will be in the Portland, Oregon area.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Nov 1, 2011
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lipoic Acid

600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)

Dietary Supplement: R-alpha lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
Other Names:
  • Thioctic acid, LA, lipoic acid

    		•
    Placebo Comparator: Placebo

    Placebo two caps every morning on empty stomach

    Dietary Supplement: Placebo
    two capsules once daily in morning on empty stomach

    Outcome Measures

    Primary Outcome Measures

    1. Triglycerides [12 weeks and 24 weeks]

    Secondary Outcome Measures

    1. Body weight and composition [12 and 24 weeks]

    2. Markers of inflammation and oxidative stress [12 and 24 weeks]

    Eligibility Criteria

    Criteria

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

    • Age 18-60

    • Overweight (BMI, 25.0-29.9 kg/m2) or obese (BMI, >30 kg/m2);

    • Elevated plasma triglycerides (100-400 mg/dl);

    • Weight stable for the last three months and at lifetime maximum;

    • Exercise limited to 30 minutes 3 times a week or less;

    • Hs-CRP level at baseline of ≤ 10 mg/L;

    • Consuming ≤ 2 alcoholic drinks per day;

    Exclusion criteria:

    • Pregnant, breastfeeding, or planning to become pregnant before the end of the study.

    • Having had acute medical conditions, such as hospitalizations or surgeries, at least three months prior to entry into the study

    • Diagnosed as having diabetes (fasting glucose <125 mg/dl for entry), cardiovascular disease, congestive heart failure, angina, thyroid disorders, cancer, inflammatory disorders or renal, hepatic, or hematological abnormalities;

    • Currently taking lipid-lowering drugs, anti-hypertensive drugs, insulin , or oral hypoglycemic agents, anti-inflammatory drugs, weight loss medications, or hormone replacement therapy;

    • On an extreme diet and not maintaining a prudent diet;

    • Currently taking vitamin or antioxidant supplements, including R-alpha lipoic acid, except standard multivitamin/mineral supplements containing not more than the Daily Value (DV) of the vitamins and minerals;

    • Smoking within the last three months;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oregon Health & Science University Portland Oregon United States 97201

    Sponsors and Collaborators

    • Oregon State University
    • Oregon Health and Science University
    • National Center for Complementary and Integrative Health (NCCIH)

    Investigators

    • Principal Investigator: Gerd Bobe, PhD, Oregon State University
    • Principal Investigator: Jonathan Q Purnell, MD, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gerd Bobe, Principal Investigator, Linus Pauling Institute; Associate Professor, Department of Animal Sciences, Oregon State University
    ClinicalTrials.gov Identifier:
    NCT00765310
    Other Study ID Numbers:
    • AT002034-1 (7186)
    • 5P01AT002034
    First Posted:
    Oct 2, 2008
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Gerd Bobe, Principal Investigator, Linus Pauling Institute; Associate Professor, Department of Animal Sciences, Oregon State University
    atherosclerosis
    lipoic acid
    thioctic acid
    triglycerides
    overweight
    obesity
    oxidative stress
    inflammation
    Additional relevant MeSH terms:
    Atherosclerosis
    Thioctic Acid

    Study Results

    No Results Posted as of Apr 21, 2022