Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

NCT06480760 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 24.0309R01HL163419
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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

Keywords

peripheral arterial disease; carnosine

Outcome Measures

Primary Outcomes (1)

• Measure distance covered on six-minute walk test (6MWT)

  Distance covered on a flat and hard surface in 6 minutes. Units: Feet

  Baseline, 3 months, 6 months, 9 months

Secondary Outcomes (19)

• Measure Ankle-Brachial Index (ABI)

  Baseline, 3 months, 6 months, 9 months

• Treadmill Testing

  Baseline, 3 months, 6 months

• Skin Integrity

  Baseline, 3 months, 6 months

• Musculoskeletal Assessment

  Baseline, 3 months, 6 months

• Neuromuscular Assessment

  Baseline, 3 months, 6 months

Study Arms (2)

Placebo

NO INTERVENTION

Cellulose

Carnosine

EXPERIMENTAL

Carnosine 2 g daily for 6 months

Drug: Carnosine

Interventions

Carnosine DRUG

Food ingredient (supplement)

Carnosine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Baba: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

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

Louisville, Kentucky, 40202, United States

RECRUITING

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

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

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

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

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MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Shahid Baba, PhD

  University of Louisville School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shahid Baba, PhD

CONTACT

502-296-7713; shahid.baba@louisville.edu

Amit Dwivedi, MD

CONTACT

502-583-8303; amit.dwivedi@louisville.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A randomized, double-blinded longitudinal study in approximately 144 PAD patients

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: May 20, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)