Recruiting
Phase 1
Phase 2

Carnosine

Sponsor:

Shahid Baba

Code:

NCT05371145

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Carnosine

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT05371145

Start date

Mar 1, 2023

Status verified date

Jul, 2024

Completion date

Dec 30, 2024

Anticipated

Primary completion date

Dec 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male subjects more than >50 to <80 years of age.
2. White or African American race.
3. English Speaking.
4. ABI 0.4-< 0.60
5. Willing to comply with protocol requirements.
6. Able to provide informed consent. -

Exclusion Criteria:

1. 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.
2. Diagnosis of carnosinemia.
3. Known allergy to L-carnosine or meat.
4. Presence of a pacemaker.
5. Obesity from a known genetic defect.
6. Dementia.
7. Critical limb ischemia with below or above knee amputations.
8. Foot ulcers.
9. Major amputations.
10. Participating in other clinical trials.
11. End stage renal disease.
12. Presence of significant injury within 30 days before enrollment.
13. Prisoners.
14. Any metallic implants.
15. Poorly controlled diabetes (HbA1C >9%) -

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carnosine intervention for patients with PAD

This is a single arm open labelled safety trial, where we will supplement carnosine for 3 months to subjects with non-claudication and claudication peripheral arterial disease (PAD), and determine if it improves walking ability.

Interventions

Carnosine

Determine whether carnosine supplementation (2 g/day) for 3 months in peripheral arterial disease patients improves 6MWT ability.

Primary outcome measure

  • Carnosine for Peripheral Arterial Disease patients [ Time Frame: One year ]

Central Contacts and Locations

Locations

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Shahid P Baba, Ph.D

502-852-4274spbaba01@louisville.edu

Amit J Dwivedi

5026450749amit.dwivedi@louisville.edu

More Information

Sponsor

Shahid Baba

Last update posted

Jul 22, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Shahid Baba on 2024-07-22.