Recruiting
Phase 1
Phase 2

Carnosine

Sponsor:

Shahid Baba

Code:

NCT06480760

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Carnosine

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT06480760

Start date

May 20, 2025

Status verified date

May, 2025

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Placebo

Cellulose

experimental: Carnosine

Carnosine 2 g daily for 6 months

Interventions

Carnosine

Food ingredient (supplement)

Primary outcome measure

  • Measure distance covered on six-minute walk test (6MWT) [ Time Frame: Baseline, 3 months, 6 months, 9 months ]

Central Contacts and Locations

Locations

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

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

More Information

Sponsor

Shahid Baba

Last update posted

May 29, 2025

Last verified

May, 2025

Keywords

  • peripheral arterial disease
  • carnosine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shahid Baba on 2025-05-29.