Carnosine for Peripheral Arterial Disease

(CAR-PAD Trial)

Age: 18+

Sex: Male

Trial Phase: Phase 1 & 2

Sponsor: Shahid Baba

Disqualifiers: HIV, Cancer, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether L-carnosine, a dietary supplement, can improve walking ability in people with peripheral arterial disease (PAD). PAD often causes leg pain and cramping due to poor blood flow. The trial provides carnosine supplements to determine if they enhance muscle health and promote the formation of new blood vessels. Individuals with PAD who experience leg pain while walking, but do not have severe conditions like liver disease or poorly controlled diabetes, may qualify as candidates. The trial spans three months, focusing on improving leg function. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that carnosine is likely to be safe for humans?

Research shows that carnosine is generally safe as a supplement. Studies have found it may benefit individuals with peripheral vascular disease, which resembles peripheral arterial disease (PAD). Although specific safety data for PAD is limited, carnosine has been tested in other conditions without major safety concerns, suggesting it is well-tolerated. Note that this information comes from early studies, and further research is underway to confirm these findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for peripheral arterial disease (PAD), like antiplatelet medications and cholesterol-lowering drugs, primarily focus on improving blood flow and preventing clots. Unlike these standard treatments, carnosine is unique because it is a naturally occurring compound with antioxidant and anti-inflammatory properties. Researchers are excited about carnosine because it may enhance muscle function and improve walking ability in PAD patients without relying on traditional blood-thinning mechanisms. By potentially targeting muscle metabolism directly, carnosine offers a novel approach that could complement existing therapies and provide additional benefits for those struggling with PAD.

What evidence suggests that carnosine might be an effective treatment for peripheral arterial disease?

Research has shown that carnosine, a natural antioxidant in the body, might benefit individuals with peripheral arterial disease (PAD). It can reduce plaque buildup in the arteries, preventing them from narrowing. Studies have found that carnosine improves blood flow and aids in forming new blood vessels. In one study with PAD patients, similar substances like L-carnitine improved walking ability. These findings suggest that carnosine might enhance muscle function in people with PAD by boosting blood flow and oxygen delivery to muscles. Participants in this trial will receive carnosine supplementation to evaluate its effects on walking ability in individuals with PAD. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men aged 50-80 with Peripheral Arterial Disease, having an ABI of 0.4 to less than 0.60, and who can follow the study rules. They must be White or African American, speak English, and give informed consent. It's not for those with severe diseases like HIV or cancer, carnosinemia, allergies to L-carnosine/meat, pacemakers/metal implants, recent major injuries/amputations/ulcers or uncontrolled diabetes.

Inclusion Criteria

Your ankle-brachial index (ABI) is between 0.4 and less than 0.60.

Willing to comply with protocol requirements

White or African American race

Exclusion Criteria

You have HIV, hepatitis, severe liver disease, active infection, anemia, organ transplant, kidney disease needing dialysis, lung disease needing oxygen, serious heart disease from birth, any type of cancer, or untreated thyroid disease.

You have been diagnosed with carnosinemia.

You are allergic to L-carnosine or meat.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carnosine supplementation (2 g/day) for 3 months to improve walking performance

12 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of walking performance and oxidative stress markers

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Carnosine

Trial Overview The trial tests if taking L-carnosine pills helps improve leg function in PAD patients by increasing muscle carnosine levels and promoting new blood vessel growth.

How Is the Trial Designed?

Group I: Carnosine intervention for patients with PAD Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Shahid Baba

Lead Sponsor

Trials

2

Recruited

140+

University of Louisville

Lead Sponsor

Trials

353

Recruited

76,400+

Published Research Related to This Trial

In a study involving 22 patients with peripheral arterial disease, L-carnitine supplementation significantly improved walking capacity in patients with low resting levels of acetylcarnitine, indicating its potential efficacy in enhancing exercise performance.

The results suggest that measuring plasma acetylcarnitine levels can help identify which patients are most likely to benefit from L-carnitine therapy, as those with elevated resting levels did not show improvement after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Carnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy. Brevetti, G., di Lisa, F., Perna, S., et al.[2019]

In a study involving 167 cases of peripheral artery disease (PAD) and 250 matched controls, higher baseline levels of plasma amino acids like tryptophan, serine, and threonine were found to be inversely associated with the risk of developing PAD, suggesting they could serve as early biomarkers for the disease.

The Mediterranean diet supplemented with extra-virgin olive oil (EVOO) was shown to provide a protective effect against PAD, regardless of baseline threonine levels, highlighting the potential of dietary interventions in reducing PAD risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circulating Amino Acids and Risk of Peripheral Artery Disease in the PREDIMED Trial. Razquin, C., Ruiz-Canela, M., Toledo, E., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05371145

Carnosine for Peripheral Arterial Disease Patients 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 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0939475322002952

Carnosine as a potential therapeutic for the management ... Carnosine is an endogenous antioxidant, with potential for significant benefit in peripheral vascular disease. · Carnosine may prevent atherosclerotic plaque ...

3. reporter.nih.gov reporter.nih.gov/search/AWeKN2SUwEq_xxSL579g7g/project-details/10982089

Role of carnosine in peripheral arterial disease Recent evidence from our laboratory shows that in addition to buffering, carnosine chelates first transition metals and improves angiogenesis, forms conjugates ...

4. clinicaltrial.be clinicaltrial.be/en/details/17143?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Carnosine for Peripheral Arterial Disease Patients - Clin... This is a single arm open labelled safety trial, where we will supplement carnosine for 3 months to subjects with non-claudication and ...

5. withpower.com withpower.com/trial/phase-2-peripheral-arterial-disease-7-2024-7f31b

Carnosine for Peripheral Arterial Disease (CIPHER Trial) In a study involving 22 patients with peripheral arterial disease, L-carnitine supplementation significantly improved walking capacity in patients with low ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35973888/

Carnosine as a potential therapeutic for the management ... Carnosine as a supplement is safe, and associated with a host of beneficial effects in peripheral vascular disease and its key risk factors.

7. withpower.com withpower.com/trial/phase-2-peripheral-arterial-disease-5-2022-43e98

Carnosine for Peripheral Arterial Disease (CAR-PAD Trial) While specific safety data for peripheral arterial disease is limited, carnosine has been evaluated for other conditions without major safety concerns.