NCT00765310

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
12.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

April 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.6 years

First QC Date

October 1, 2008

Last Update Submit

April 8, 2025

Conditions

Atherosclerosis

Keywords

atherosclerosislipoic acidthioctic acidtriglyceridesoverweightobesityoxidative stressinflammation

Outcome Measures

Primary Outcomes (1)

  • Triglycerides

    12 weeks and 24 weeks

Secondary Outcomes (2)

  • Body weight and composition

    12 and 24 weeks

  • Markers of inflammation and oxidative stress

    12 and 24 weeks

Study Arms (2)

Lipoic Acid

ACTIVE COMPARATOR

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

Dietary Supplement: R-alpha lipoic acid

Placebo

PLACEBO COMPARATOR

Placebo two caps every morning on empty stomach

Dietary Supplement: Placebo

Interventions

R-alpha lipoic acidDIETARY_SUPPLEMENT

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

Also known as: Thioctic acid, LA, lipoic acid
Lipoic Acid
PlaceboDIETARY_SUPPLEMENT

two capsules once daily in morning on empty stomach

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97201, United States

Location

Related Publications (1)

  • 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.

    PMID: 32692358DERIVED

MeSH Terms

Conditions

AtherosclerosisOverweightObesityInflammation

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Gerd Bobe, PhD

    Oregon State University

    PRINCIPAL INVESTIGATOR

  • Jonathan Q Purnell, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Linus Pauling Institute; Associate Professor, Department of Animal Sciences

Study Record Dates

First Submitted

October 1, 2008

First Posted

October 2, 2008

Study Start

April 1, 2009

Primary Completion

November 1, 2011

Study Completion

October 1, 2024

Last Updated

April 11, 2025

Record last verified: 2025-04

Locations

US(1)