NCT05371145 · Shahid Baba
Carnosine for Peripheral Arterial Disease Patients
(CAR-PAD)
What this study is about
taken by mouth supplementation of L-carnosine will increase muscle carnosine, stabilize HIF1-alpha promote angiogenesis, and thus improve the functioning of lower extremities in PAD patients.
View original scientific description
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.
Interventions
BIOLOGICAL
Carnosine
Determine whether carnosine supplementation (2 g/day) for 3 months in peripheral arterial disease patients improves 6MWT ability.
Primary outcome measures
Carnosine for Peripheral Arterial Disease patients
Time frame: One year
Compare the effects of carnosine supplementation on the 6-minute walk test (6MWT) at the baseline and after three months of carnosine supplementation. Measure the total walking distance and compare the walking distance covered by the subjects at the start and completion of carnosine supplementation
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
- 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.
- Any metallic implants.
- Poorly controlled diabetes (HbA1C \>9%) -
Where
- Louisville, Kentucky
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 22, 2024 · Source of record for eligibility and locations