RecruitingPhase 1Phase 2NCT05371145
Carnosine for Peripheral Arterial Disease Patients
Carnosine for Peripheral Arterial Disease Patients (Car-PAD)
Sponsor
Shahid Baba
Enrollment
20 participants
Start Date
Mar 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Oral supplementation of L-carnosine will increase muscle carnosine, stabilize HIF1-alpha promote angiogenesis, and thus improve the functioning of lower extremities in PAD patients.
Eligibility
Sex: MALEMin Age: 50 YearsMax Age: 80 Years
Inclusion Criteria6
- Male subjects more than >50 to <80 years of age.
- White or African American race.
- English Speaking.
- ABI 0.4-< 0.60
- Willing to comply with protocol requirements.
- Able to provide informed consent. -
Exclusion Criteria15
- Subjects with HIV, hepatitis, significant liver disease, active infection, anemia, organ transplant, renal disease requiring dialysis, lung disease requiring oxygen, significant congenital heart disease, cancer of any type, and untreated thyroid disease.
- Diagnosis of carnosinemia.
- Known allergy to L-carnosine or meat.
- Presence of a pacemaker.
- Obesity from a known genetic defect.
- Dementia.
- Critical limb ischemia with below or above knee amputations.
- Foot ulcers.
- Major amputations.
- Participating in other clinical trials.
- End stage renal disease.
- Presence of significant injury within 30 days before enrollment.
- Prisoners.
- Any metallic implants.
- Poorly controlled diabetes (HbA1C >9%) -
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Interventions
BIOLOGICALCarnosine
Determine whether carnosine supplementation (2 g/day) for 3 months in peripheral arterial disease patients improves 6MWT ability.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05371145
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