Lipoic Acid and Prevention of Heart Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-01

Study Completion Date

2024-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lipoic Acid

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

Group Type ACTIVE_COMPARATOR

R-alpha lipoic acid

Intervention Type DIETARY_SUPPLEMENT

600 mg in morning on empty stomach (two 300 mg capsules)

Placebo

Placebo two caps every morning on empty stomach

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

two capsules once daily in morning on empty stomach

Interventions

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R-alpha lipoic acid

600 mg in morning on empty stomach (two 300 mg capsules)

Intervention Type DIETARY_SUPPLEMENT

Placebo

two capsules once daily in morning on empty stomach

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Thioctic acid, LA, lipoic acid

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes