Actively Recruiting
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
Led by Shahid Baba · Updated on 2025-05-29
144
Participants Needed
3
Research Sites
175 weeks
Total Duration
On this page
Sponsors
S
Shahid Baba
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants between 40-80 years of age
- White or African American race
- Literate in English
- Ankle-Brachial Index (ABI) greater than 0.4 and less than 0.90, measured within 6 weeks before enrollment
- Willing and able to follow study procedures
- Able to provide informed consent
You will not qualify if you...
- HIV, hepatitis, significant liver disease, anemia, kidney disease requiring dialysis, lung disease requiring home oxygen, or active cancer, as determined by physician
- Critical limb ischemia with leg amputation or foot ulcers on the affected leg
- Significant injury within 30 days or vascular intervention on affected leg within 6 months before enrollment
- Baseline six-minute walk test distance less than 152.0 meters (498 feet) or more than 487.7 meters (1600 feet)
- Known allergy to L-carnosine
- Rare metabolic disorders like carnosinemia or carnosinase deficiency
- Currently enrolled in other clinical trials
- Previous participation in carnosine supplementation trials
- Currently taking carnosine supplements
- Unable to provide a urine sample (anuric)
- Pregnant participants
- Using dual antiplatelet therapies (exclusion from biopsy)
- Internal metal objects preventing MRI or 1HMRS scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine
Louisville, Kentucky, United States, 40202
Actively Recruiting
2
University Surgical Associates, 401 E. Chestnut St, Suite 710
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
3
UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
Research Team
S
Shahid Baba, PhD
CONTACT
A
Amit Dwivedi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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