Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients; Randomized Intervention Trial (CIPHER)
Shahid Baba
144 participants
May 20, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to determine whether carnosine (a food ingredient found in chicken and red meat) supplementation (2 g) for 6 months in participants with non-claudication and claudication peripheral arterial disease (PAD) improves walking ability. Previous studies with heart failure patients have shown that carnosine supplementation increases walking capacity in these patients.
Eligibility
Inclusion Criteria6
- Participants between 40-80 years of age.
- White or African American race.
- Literate in English.
- ABI >0.4-<0.90, obtained within 6 weeks from enrollment.
- Willing and able to comply with protocol requirements.
- Participant is able to provide informed consent.
Exclusion Criteria13
- 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.
- Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
- Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's discretion.
- Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
- Known allergy to L-carnosine.
- Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
- Currently participating in other clinical trials.
- Participation in any carnosine supplementation clinical trial anytime in the past.
- Participants already taking carnosine.
- Participants unable to provide urine sample (anuric).
- Pregnant participants.
- Participants using dual antiplatelet therapies will not be included for biopsy.
- Participants with internal metallic objects in body will not be eligible for MRI or 1HMRS.
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Interventions
Food ingredient (supplement)
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06480760