Carnosine for Peripheral Arterial Disease

(CIPHER Trial)

Recruiting at 2 trial locations

Overseen By Shahid Baba, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Shahid Baba

Must not be taking: Dual antiplatelets

Disqualifiers: HIV, Cancer, Renal disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

144 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if carnosine, a natural compound in foods like chicken and red meat, can improve walking ability in people with peripheral arterial disease (PAD). Participants will receive either carnosine or a placebo (a pill with no active ingredient) for six months. The study seeks individuals with PAD who do not have severe symptoms such as chronic limb pain or ulcers. Those who have difficulty walking due to PAD and meet the criteria may find this trial suitable. As a Phase 1, Phase 2 trial, the research focuses on understanding the treatment's mechanism and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using dual antiplatelet therapies, you will be excluded from the muscle biopsy part of the study.

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 to be well-tolerated with few side effects. Testing in people with various health conditions has revealed no major safety issues. Although limited safety data exists for individuals with peripheral arterial disease (PAD), carnosine has been used safely in other contexts. This suggests it could be a safe option for those considering this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Peripheral Arterial Disease (PAD) that often focus on improving blood flow through medication or surgery, carnosine is unique because it acts as a powerful antioxidant. Carnosine helps to reduce oxidative stress and inflammation in the body, which are key contributors to the progression of PAD. Researchers are excited about carnosine because it could potentially offer a non-invasive, daily supplement option that targets the underlying causes of PAD, rather than just alleviating its symptoms.

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

Research shows that carnosine supplements can help people with peripheral arterial disease (PAD) walk better. In this trial, participants will receive either carnosine or a placebo. Previous studies found that patients with reduced blood flow to their legs improved their walking ability after using carnosine. Other research indicates that carnosine can boost exercise performance by increasing its levels in muscles. Additionally, carnosine helps blood vessels grow by enhancing a factor called VEGF. These findings suggest that carnosine could effectively improve walking for PAD patients. ^{1 3 5 6 7}

Who Is on the Research Team?

Shahid Baba, PhD

Principal Investigator

University of Louisville School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with Peripheral Arterial Disease (PAD), which affects blood flow in the legs, causing pain or difficulty walking. Participants should be experiencing symptoms of PAD but not necessarily severe enough to prevent walking (non-claudication or claudication). Key eligibility details are not provided.

Inclusion Criteria

I am between 50 and 80 years old.

ABI 0.4-<0.90

Willing to comply with protocol requirements

Exclusion Criteria

I do not have HIV, hepatitis, significant liver disease, active infections, anemia, organ transplant, renal disease requiring dialysis, lung disease requiring oxygen, significant congenital heart disease, any type of cancer, or untreated thyroid disease.

I have been diagnosed with carnosinemia.

My obesity is due to a genetic condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carnosine or placebo supplementation for 6 months to assess improvements in walking ability and other health metrics

6 months

Regular visits for assessments and measurements

Follow-up

Participants are monitored for the durability of carnosine supplementation effects

3 months

Follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Carnosine

Trial Overview The study tests if taking carnosine, a dietary supplement found in chicken and red meat, can improve walking ability over six months. This follows observations that heart failure patients improved their walking capacity with carnosine.

How Is the Trial Designed?

Group I: Carnosine Experimental Treatment 1 Intervention

Carnosine 2 g daily for 6 months

Group II: Placebo Active Control 1 Intervention

Cellulose

Who Is Running the Clinical Trial?

Shahid Baba

Lead Sponsor

Trials

2

Recruited

140+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

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 Numerous studies have shown that the supplementation of beta-alanine or carnosine increases the levels of carnosine in the skeletal muscle and improves the ...

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

Role of carnosine in peripheral arterial disease Abstract A food supplement carnosine can improve the walking ability of patients having leg ischemia. NIH Spending Category. Atherosclerosis Cardiovascular ...

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

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

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... Mechanistic studies showed that the metal quenching ability of carnosine increased the expression of angiogenic factor VEGF and endothelial ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04870229

NCT04870229 | Carnosine for Peripheral Arterial Disease Numerous studies have shown that the supplementation of -alanine increases the levels of carnosine in the skeletal muscle and improves the exercise performance ...

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

Carnosine as a potential therapeutic for the management ... Carnosine is safe, with few reported side effects, making it suitable for use in vulnerable populations.