Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

Description

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.

Conditions

Peripheral Arterial Disease

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Study Overview

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Study Details

Study overview

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.

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

Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

Condition
Peripheral Arterial Disease
Intervention / Treatment

-

Contacts and Locations

Louisville

University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine, Louisville, Kentucky, United States, 40202

Louisville

University Surgical Associates, 401 E. Chestnut St, Suite 710, Louisville, Kentucky, United States, 40202

Louisville

UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004, Louisville, Kentucky, United States, 40202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Shahid Baba,

Shahid Baba, PhD, PRINCIPAL_INVESTIGATOR, University of Louisville School of Medicine

Study Record Dates

2028-10-01