Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
NCT ID: NCT06480760
Last Updated: 2025-05-29
Study Results
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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RECRUITING
PHASE1/PHASE2
144 participants
INTERVENTIONAL
2025-05-20
2028-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Cellulose
No interventions assigned to this group
Carnosine
Carnosine 2 g daily for 6 months
Carnosine
Food ingredient (supplement)
Interventions
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Carnosine
Food ingredient (supplement)
Eligibility Criteria
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Inclusion Criteria
2. White or African American race.
3. Literate in English.
4. ABI \>0.4-\<0.90, obtained within 6 weeks from enrollment.
5. Willing and able to comply with protocol requirements.
6. Participant is able to provide informed consent.
Exclusion Criteria
2. Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
3. Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's discretion.
4. Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
5. Known allergy to L-carnosine.
6. Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
7. Currently participating in other clinical trials.
8. Participation in any carnosine supplementation clinical trial anytime in the past.
9. Participants already taking carnosine.
10. Participants unable to provide urine sample (anuric).
11. Pregnant participants.
12. Participants using dual antiplatelet therapies will not be included for biopsy.
13. Participants with internal metallic objects in body will not be eligible for MRI or 1HMRS.
40 Years
80 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Shahid Baba
OTHER
Responsible Party
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Shahid Baba
Professor
Principal Investigators
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Shahid Baba, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Louisville School of Medicine
Locations
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University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine
Louisville, Kentucky, United States
University Surgical Associates, 401 E. Chestnut St, Suite 710
Louisville, Kentucky, United States
UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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24.0309
Identifier Type: -
Identifier Source: org_study_id
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