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

Trial Summary

What is the purpose of this trial?

This trial tests if taking L-carnosine supplements can help people with PAD improve their leg function and walk more easily by promoting new blood vessel growth and reducing muscle stress. Carnosine is a dipeptide stored in muscle and brain tissue, known for its antioxidant properties and potential benefits in managing peripheral vascular disease.

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.

What evidence supports the effectiveness of the treatment carnosine for peripheral arterial disease?

Carnosine has shown potential benefits in animal studies for improving cardiovascular risk factors due to its anti-inflammatory and antioxidant properties, but there is limited evidence in humans. Some studies suggest it may help with conditions related to diabetes and cardiovascular health, but more research is needed to confirm its effectiveness in humans. ^{1 2 3 4 5}

Is carnosine safe for humans?

Carnosine is generally considered safe for humans, as it is a naturally occurring compound in the body and has been studied for its potential to neutralize harmful substances. While specific safety data for peripheral arterial disease is limited, carnosine has been evaluated for other conditions without major safety concerns. ^{6 7 8 9 10}

How does the drug Carnosine differ from other treatments for peripheral arterial disease?

Carnosine is unique because it is being explored for its potential role in managing peripheral vascular disease, which is a novel approach compared to traditional treatments. Unlike other therapies that focus on improving blood flow or correcting metabolic alterations, Carnosine may offer benefits through its antioxidant properties and ability to protect against oxidative stress, which could help improve vascular health. ^{6 7 9 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Carnosine Did Not Affect Vascular and Metabolic Outcomes in Patients with Prediabetes and Type 2 Diabetes: A 14-Week Randomized Controlled Trial. [2023]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

L-carnosine and its Derivatives as New Therapeutic Agents for the Prevention and Treatment of Vascular Complications of Diabetes. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Use of carnosine in the prevention of cardiometabolic risk factors in overweight and obese individuals: study protocol for a randomised, double-blind placebo-controlled trial. [2021]

4. Czech Republic pubmed.ncbi.nlm.nih.gov

Supplementation-induced change in muscle carnosine is paralleled by changes in muscle metabolism, protein glycation and reactive carbonyl species sequestering. [2023]

5. Austria pubmed.ncbi.nlm.nih.gov

Physiological and therapeutic effects of carnosine on cardiometabolic risk and disease. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Carnosine as a potential therapeutic for the management of peripheral vascular disease. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Asymmetric dimethylarginine predicts major adverse cardiovascular events in patients with advanced peripheral artery disease. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Dietary intake and cardiovascular outcomes in patients with chronic vascular disease: insights from the COMPASS trial cohort. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Carnitine-related alterations in patients with intermittent claudication: indication for a focused carnitine therapy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Protocol to assess the efficacy of carnosine supplementation in mitigating the adverse cardiovascular responses to particulate matter (PM) exposure: the Nucleophilic Defense Against PM Toxicity (NEAT) trial. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Circulating Amino Acids and Risk of Peripheral Artery Disease in the PREDIMED Trial. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Propionyl l-carnitine: intermittent claudication and peripheral arterial disease. [2020]