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Lipoic Acid and Prevention of Heart Disease

Primary Purpose

Atherosclerosis

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
R-alpha lipoic acid
Placebo
Sponsored by
Oregon State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atherosclerosis focused on measuring atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lipoic Acid

Placebo

Arm Description

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

Placebo two caps every morning on empty stomach

Outcomes

Primary Outcome Measures

Triglycerides

Secondary Outcome Measures

Body weight and composition
Markers of inflammation and oxidative stress

Full Information

First Posted
October 1, 2008
Last Updated
April 19, 2022
Sponsor
Oregon State University
Collaborators
Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00765310
Brief Title
Lipoic Acid and Prevention of Heart Disease
Official Title
The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon State University
Collaborators
Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lipoic Acid
Arm Type
Active Comparator
Arm Description
600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo two caps every morning on empty stomach
Intervention Type
Dietary Supplement
Intervention Name(s)
R-alpha lipoic acid
Other Intervention Name(s)
Thioctic acid, LA, lipoic acid
Intervention Description
600 mg in morning on empty stomach (two 300 mg capsules)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
two capsules once daily in morning on empty stomach
Primary Outcome Measure Information:
Title
Triglycerides
Time Frame
12 weeks and 24 weeks
Secondary Outcome Measure Information:
Title
Body weight and composition
Time Frame
12 and 24 weeks
Title
Markers of inflammation and oxidative stress
Time Frame
12 and 24 weeks

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: 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerd Bobe, PhD
Organizational Affiliation
Oregon State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Q Purnell, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32692358
Citation
Bobe G, Michels AJ, Zhang WJ, Purnell JQ, Woffendin C, Pereira C, Vita JA, Thomas NO, Traber MG, Frei B, Hagen TM. A Randomized Controlled Trial of Long-Term (R)-alpha-Lipoic Acid Supplementation Promotes Weight Loss in Overweight or Obese Adults without Altering Baseline Elevated Plasma Triglyceride Concentrations. J Nutr. 2020 Sep 1;150(9):2336-2345. doi: 10.1093/jn/nxaa203.
Results Reference
derived

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Lipoic Acid and Prevention of Heart Disease

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