Effects of Carnosine In Patients With Peripheral Arterial Disease Patients

Launched by SHAHID BABA · Jun 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called carnosine, which is found in foods like chicken and red meat, on people with Peripheral Arterial Disease (PAD). PAD can cause pain and discomfort in the legs when walking due to reduced blood flow. The researchers want to see if taking 1 gram of carnosine daily for six months can help improve walking ability in individuals with PAD, whether they experience pain while walking (claudication) or not. Previous studies have suggested that carnosine may help increase walking capacity in heart failure patients, and now they want to see if it works similarly for those with PAD.

To participate in this study, you need to be between 40 and 80 years old and able to speak English. You should also be willing to follow the study's guidelines and provide consent to participate. However, some people may not be eligible, such as those with certain medical conditions like liver disease, cancer, or severe diabetes, as well as those recently injured or participating in other clinical trials. If you qualify, you can expect to take the supplement for six months and possibly see improvements in your walking ability, which could enhance your overall quality of life.

Gender

ALL

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.