RecruitingPhase 1Phase 2NCT06480760

Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

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


Sponsor

Shahid Baba

Enrollment

144 participants

Start Date

May 20, 2025

Study Type

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

Min Age: 40 YearsMax Age: 80 Years

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

DRUGCarnosine

Food ingredient (supplement)


Locations(3)

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

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NCT06480760


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