Effects of Carnosine In Patients With Peripheral Arterial Disease Patients
NCT Number: NCT06480760
Acronym: CIPHER
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Peripheral Arterial Disease
Interventions: DRUG: Carnosine
Sponsor: Shahid Baba
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2027-08-01
Locations: University of Louisville School of Medicine, Department of Medicine, Division of Environmental Medicine, Louisville, Kentucky, 40202, United States

Summary:
The purpose of this study is to determine whether carnosine (a food ingredient found in chicken and red meat) supplementation (1 g) for 6 months in subjects with peripheral arterial disease (PAD); non-claudication or claudication) improves your walking ability. Previous studies with heart failure patients had shown that carnosine supplementation increases walking capacity in these patients.

Primary Outcome Measures: Measure distance covered on six-minute walk tes, Distance covered on a flat and hard surface in 6 minutes. Units: Feet, Baseline, 12 months|Measure Ankle-Brachial Index (ABI), Ratio of blood pressure measurements from the arms and ankles. Units: Normal range 1.0-1.4 and lower than 0.9 is an indication of peripheral arterial disease, Baseline,12 months|Treadmill testing, Graded treadmill testing until the onset of the maximal claudication pain. Units: Meters, Baseline,12 months|Skin integrity, Check the color, trophic changes and flakes. Units: None, Baseline, 12 months|Musculoskeletal assessment, Perform goniometric measurements.

Units: Visual analog scale (VAS 0-10); 0-10 corresponds to the no pain to severe pain., Baseline, 12 months|Neuromuscular assessment, For neuromuscular assessment assess the sharp-dull and deep pressure sensation. Units: None, Baseline, 12 months|Balance assessment, Balance assessment will be measured by dynamic gait index. Units: Scale 0 to 3, with 3 indicating normal and 0 representing severe impairment, Baseline, 12 months|Blood flow measurements, Handheld Laser Doppler flowmetry to measure microflow. Units: An arbitrary scale of 0 to 10; results will be expressed as mL/min, Baseline,12 months|Quality of life questionnaire, Health related quality of life using a Short-Form 36 general health survey. Units: An arbitrary scale 0 to 100, with higher scores representing better health., Baseline,12 months|Daily walking ability, Steps over a period of 6 days using triaxial pedometer. Units: Step counts, Baseline,12 months|Blood collection and analysis, White blood cells, red blood cells. Units: Cells per cubic millimeter. Neutrophils, lymphocytes, monocytes, eosinophils, basophils. Units: percent, Baseline, 12 months|Blood collection and analysis, 10. Sodium, phosphate, chloride, calcium, glucose, creatinine, albumin, ALT and AST Units: mg/dL, Baseline, 12 months|Measurement of carnosine in blood and urine, Using mass spec will measure carnosine bioavailability. Units: moles, Baseline,12 months|Measure angiogenic cell population., Flow cytometry: measure angiogenic cell population. Units: Number of cells, Baseline,12 months|Mitochondrial abundance measurements, Perform RTPCR to measure expression of different mitochondrial genes. Units: Relative mRNA expression, Baseline,12 months|Measurement of carnosine in muscle, Using magnetic resonance spectroscopy, will measure carnosine accumulation before and after supplementation.

Units: millimole., Baseline, 12 months|Measurement of blood flow, Using magnetic resonance imaging will measure blood flow in the legs. Units: mL/min, Baseline,12 months