Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Carnosine

Food ingredient (supplement)

Locations (3)

University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine
Louisville, Kentucky, United States
University Surgical Associates, 401 E. Chestnut St, Suite 710
Louisville, Kentucky, United States
UofL Physicians - Vascular Surgery Associates, 201 Abraham Flexner Way, Suite 1004
Louisville, Kentucky, United States