NCT06480760 Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
| NCT ID | NCT06480760 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shahid Baba |
| Condition | Peripheral Arterial Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 144 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 144 participants in total. It began in 2025-05-20 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Shahid Baba, PhD
PRINCIPAL INVESTIGATOR
University of Louisville School of Medicine
Frequently Asked Questions
Who can join the NCT06480760 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Peripheral Arterial Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06480760 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06480760 currently recruiting?
Yes, NCT06480760 is actively recruiting participants. Contact the research team at shahid.baba@louisville.edu for enrollment information.
Where is the NCT06480760 trial being conducted?
This trial is being conducted at Louisville, United States, Louisville, United States, Louisville, United States.
Who is sponsoring the NCT06480760 clinical trial?
NCT06480760 is sponsored by Shahid Baba. The principal investigator is Shahid Baba, PhD at University of Louisville School of Medicine. The trial plans to enroll 144 participants.