AtherosclerosisPhase 1NCT00765310
Lipoic Acid and Prevention of Heart Disease
A Phase 1 study testing R-alpha lipoic acid in people with Atherosclerosis, run by Oregon State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- R-alpha lipoic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2009to 1 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97201
About this study
Official title: The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
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.
Read the 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.
- Conditions
- Atherosclerosis
- Being tested
- R-alpha lipoic acid, Placebo
- Keywords
- atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
- Medical subject headings
- Atherosclerosis, Overweight, Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R-alpha lipoic acidDietary supplement
Also called Thioctic acid, LA, lipoic acid
600 mg in morning on empty stomach (two 300 mg capsules)
PlaceboDietary supplement
two capsules once daily in morning on empty stomach
| Study group | Role | What they receive |
|---|---|---|
| Lipoic Acid | Active comparator | 600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules) Receives: Dietary Supplement: R-alpha lipoic acid |
| Placebo | Placebo comparator | Placebo two caps every morning on empty stomach Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Triglycerides
Measured: 12 weeks and 24 weeks
Secondary outcomes (2)
Body weight and composition
Measured: 12 and 24 weeks
Markers of inflammation and oxidative stress
Measured: 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study start1 Apr 2009
- Primary completion1 Nov 2011
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Gerd Bobe, Oregon State University
- Investigators
- Gerd Bobe, PhD, Principal investigator, Oregon State UniversityJonathan Q Purnell, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00765310
- Sponsor's protocol ID
- AT002034-1 (7186)
- Other IDs
- 5P01AT002034
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2008
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32692358
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of R-alpha Lipoic Acid in Prevention of Atherosclerotic Vascular Disease
- ClinicalTrials.gov ID
- NCT00765310
- Acronym / sponsor ID
- AT002034-1 (7186)
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- Oregon Health and Science University, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 1 Nov 2011 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lipoic Acid | Active comparator | Dietary Supplement: R-alpha lipoic acid600 mg R-alpha lipoic acid in morning on empty stomach (two 300 mg capsules) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo two caps every morning on empty stomach |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| R-alpha lipoic acidAlso: Thioctic acid, LA, lipoic acid600 mg in morning on empty stomach (two 300 mg capsules) | Dietary supplement | Lipoic Acid |
| Placebotwo capsules once daily in morning on empty stomach | Dietary supplement | Placebo |
Primary outcome
Triglycerides
Time frame: 12 weeks and 24 weeks
2 secondary outcomes
Body weight and composition
Time frame: 12 and 24 weeks
Markers of inflammation and oxidative stress
Time frame: 12 and 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Derived from this study: PubMed 32692358Bobe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerd Bobe, PhD principal investigator
Oregon State University
Jonathan Q Purnell, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing R-alpha lipoic acid in people with Atherosclerosis, run by Oregon State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Triglycerides (time frame: 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00765310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025; AzTrials last refreshed its copy on 8 Nov 2026.