Carnosine supplementation for improving walking ability in patients with peripheral arterial disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the effects of carnosine supplementation (2 g daily for 6 months) on walking ability in patients with peripheral arterial disease (PAD), both with and without claudication. A total of 144 participants will be randomly assigned to receive either carnosine or a placebo, with their walking capacity assessed through the 6-minute walk test and treadmill tests before and after the intervention. Additional measurements will include ankle-brachial index, blood flow via MRI, and various metabolic profiles. The study will also follow participants for 3 months post-supplementation to assess the durability of any observed effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants between 40-80 years of age.
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:

1. As per physician's discretion, participants with HIV, hepatitis, significant liver disease, anemia, renal disease requiring dialysis, lung disease requiring home oxygen therapy, and active cancer may be excluded.
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.

Where it's running

• University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine
  Louisville, Kentucky, United States Recruiting
• University Surgical Associates, 401 E. Chestnut St, Suite 710
  Louisville, Kentucky, United States Not yet recruiting
• UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004
  Louisville, Kentucky, United States Not yet recruiting

Study contacts

• Principal investigator: Shahid Baba, PhD — University of Louisville School of Medicine
• Study coordinator: Shahid Baba, PhD
• Email: shahid.baba@louisville.edu
• Phone: 502-296-7713

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.