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Carnosine for Peripheral Arterial Disease (CIPHER Trial)

Phase 1 & 2
Waitlist Available
Led By Shahid Baba, PhD
Research Sponsored by Shahid Baba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects between 50-80 years of age
Be older than 18 years old
Must not have
Diagnosis of carnosinemia
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline,12 months
Awards & highlights

Summary

This trial aims to investigate if taking carnosine, a substance found in chicken and red meat, can improve walking ability in people with peripheral arterial disease. Previous research in heart failure patients has suggested that

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Specific side effects of carnosine supplementation are not detailed here; however, as a naturally occurring substance in common foods, it may be well-tolerated. Any potential side effects will likely be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with carnosinemia.
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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.
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My obesity is due to a genetic condition.
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I have severe leg circulation problems leading to amputations or foot ulcers.
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My diabetes is not well-controlled (HbA1c >9%).
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My walking test result is between 498ft and 1600ft.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Balance assessment
Blood collection and analysis
Blood flow measurements
+13 more

Side effects data

From 2012 Phase 2 trial • 33 Patients • NCT00810368
8%
Hypergammaglobulinemia
8%
Costochondritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Carnosine Treatment Group
Placebo Control Group

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: CarnosineExperimental Treatment1 Intervention
Carnosine 1 g daily for 6 months
Group II: PlaceboActive Control1 Intervention
Cellulose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carnosine
2008
Completed Phase 2
~230

Find a Location

Who is running the clinical trial?

Shahid BabaLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
20 Patients Enrolled for Peripheral Arterial Disease
Shahid Baba, PhDPrincipal InvestigatorUniversity of Louisville School of Medicine
~80 spots leftby Aug 2027
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