AtherosclerosisPhase 2/3NCT00764270
The Role of R-Alpha Lipoic Acid in the Treatment of Atherosclerotic Vascular Disease
A Phase 2/3 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 in people with documented heart disease and increased levels of inflammation. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- R-alpha lipoic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2011to 1 Oct 2024
- Phase
- Phase 2/3
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
- Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
- Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
- On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
- No tobacco use within 3 months of the study
- No laboratory evidence of renal, hepatic, or hematological abnormalities
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- Not 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;
- Elevated levels of urinary and plasma F2-isoprostanes
- Elevated plasma levels of hs-CRP
Who cannot join
None listed.
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 the Treatment 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 in people with documented heart disease and increased levels of inflammation.
- Conditions
- Atherosclerosis
- Being tested
- R-alpha lipoic acid
- 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
300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lipoic acid treatment | Active comparator | Participants take lipoic acid with a washout period before or after placebo. Receives: Dietary Supplement: R-alpha lipoic acid |
| Placebo treatment | Placebo comparator | Participants take placebo with a washout period before or after lipoic acid treatment Receives: Dietary Supplement: R-alpha lipoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
hs-CRP
High sensitive C-reactive protein
Measured: 12,20 & 32 weeks
Secondary outcomes (1)
8-lso-PGF2a
8-iso-prostaglandin F2alpha
Measured: 12, 20 & 32 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 Aug 2011
- 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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764270
- Sponsor's protocol ID
- AT002034-2 (7187)
- Other IDs
- 5P01AT002034
- Status last verified
- Mar 2025
- First submitted
- 1 Oct 2008
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
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 the Treatment of Atherosclerotic Vascular Disease
- ClinicalTrials.gov ID
- NCT00764270
- Acronym / sponsor ID
- AT002034-2 (7187)
- Conditions
- Atherosclerosis
- Keywords
- atherosclerosis, lipoic acid, thioctic acid, triglycerides, overweight, obesity, oxidative stress, inflammation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 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 Aug 2011 (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 in people with documented heart disease and increased levels of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover study in which participants are randomly assigned to the sequence of receiving R-Alpha Lipoic Acid and Placebo
| Arm | Type | Receives |
|---|---|---|
| Lipoic acid treatment | Active comparator | Dietary Supplement: R-alpha lipoic acidParticipants take lipoic acid with a washout period before or after placebo. |
| Placebo treatment | Placebo comparator | Dietary Supplement: R-alpha lipoic acidParticipants take placebo with a washout period before or after lipoic acid treatment |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Documented congestive heart disease (CHD)(defined as at least one significant coronary stenosis > 50% on angiography, or history of documented myocardial infarction)
- Not diagnosed with unstable angina, uncontrolled hypertension, heart failure, recent myocardial infarction (within last six months)
- Not taking insulin or oral hypoglycemic agents, anti-inflammatory drugs other than aspirin, or hormone replacement therapy
- On stable doses for four weeks prior to entry of lipid-lowering therapy (statins), aspirin, and angiotensin-converting enzyme inhibitors or other blood pressure medications. P
- No tobacco use within 3 months of the study
Key exclusion criteria (0 listed)
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 acid300 mg R-alpha lipoic acid or placebo twice daily for 12 weeks, followed by a washout period of 12 weeks, followed by another treatment phase of the other treatment placebo or 300 mg R-alpha-lipoic acid for 12 weeks | Dietary supplement | Lipoic acid treatment, Placebo treatment |
Primary outcome
hs-CRP
Time frame: 12,20 & 32 weeks
High sensitive C-reactive protein
1 secondary outcome
8-lso-PGF2a
Time frame: 12, 20 & 32 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 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 9 inclusion and 0 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
hs-CRP (time frame: 12,20 & 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.