RECRUITING

Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-20

Study Completion:2028-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06480760

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Shahid Baba, PhD

CONTACT

502-296-7713

shahid.baba@louisville.edu

Amit Dwivedi, MD

CONTACT

502-583-8303

amit.dwivedi@louisville.edu

Principal Investigator

Shahid Baba, PhD

PRINCIPAL_INVESTIGATOR

University of Louisville School of Medicine

Study Locations (Sites)

University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine

Louisville, Kentucky, 40202

United States

University Surgical Associates, 401 E. Chestnut St, Suite 710

Louisville, Kentucky, 40202

United States

UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004

Louisville, Kentucky, 40202

United States

Collaborators and Investigators

Sponsor: Shahid Baba

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-20

Study Completion Date2028-10-01

Study Record Updates

Study Start Date2025-05-20

Study Completion Date2028-10-01

Terms related to this study

Keywords Provided by Researchers

peripheral arterial disease
carnosine

Additional Relevant MeSH Terms

Peripheral Arterial Disease