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

Effects of Carnosine In Patients With Peripheral Arterial Disease Patients; Randomized Intervention Trial (CIPHER)

This study is testing if taking carnosine for six months can help people with peripheral arterial disease walk better.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University of Louisville (Academic / other)
• Locations: 3 sites (Louisville, Kentucky and 2 other locations)
• Trial ID: NCT06480760 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-80 with non-claudication or claudication peripheral arterial disease and an ankle-brachial index between 0.4 and 0.9.

Not a fit: Patients with critical limb ischemia, significant comorbidities, or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance walking ability and overall quality of life for patients suffering from peripheral arterial disease.

How similar studies have performed: Previous studies have indicated that carnosine supplementation may improve walking capacity in other patient populations, suggesting potential for success in this context.

Eligibility criteria

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 this trial is running

Louisville, Kentucky and 2 other locations

• 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

Conditions Peripheral Arterial Disease; peripheral arterial disease; carnosine