Effects of Carnosine In Patients With Peripheral Arterial Disease Patients; Randomized Intervention Trial (CIPHER)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 144
- 试验地点
- 3
- 主要终点
- Measure distance covered on six-minute walk test (6MWT)
研究概览
简要总结
The purpose of this study is to determine whether carnosine (a food ingredient found in chicken and red meat) supplementation (2 g) for 6 months in participants with non-claudication and claudication peripheral arterial disease (PAD) improves walking ability. Previous studies with heart failure patients have shown that carnosine supplementation increases walking capacity in these patients.
详细描述
The objective of this double-blinded longitudinal study is to determine whether carnosine supplementation (2 g) for 6 months in participants with non-claudication and claudication peripheral arterial disease (PAD) improves walking ability. In this pilot study we will enroll 144 participants that will be divided into placebo (n=72) and carnosine groups (n=72). We will measure the distance covered on the 6-minute walk test (6-MWT) and the pain free walking capacity on the treadmill before and after the placebo or carnosine supplementation. We will measure ankle branchial index (ABI) and blood flow by magnetic resonance imaging (MRI) before and after the carnosine and placebo supplementation. In addition, we will measure carnosine by 1HMRS (Proton magnetic resonance spectroscopy), perform, global metabolomics and proteomics in the skeletal muscle, a comprehensive lipid and metabolic profile of blood, uptake of carnosine in red blood cells (RBCs), and measure carnosine aldehyde conjugates in the urine before and after 6 months of carnosine and placebo supplementation. Following completion of the study, we will follow the participants for another 3 months and examine the durability of carnosine supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants between 40-80 years of age.
- •White or African American race.
- •Literate in English.
- •ABI >0.4-<0.90, obtained within 6 weeks from enrollment.
- •Willing and able to comply with protocol requirements.
- •Participant is able to provide informed consent.
排除标准
- •As per physician's discretion, participants with HIV, hepatitis, significant liver disease, anemia, renal disease requiring dialysis, lung disease requiring home oxygen therapy, and active cancer may be excluded.
- •Critical limb ischemia with below or above the knee amputations or any form of foot ulceration over the symptomatic leg.
- •Presence of significant injury within 30 days, or vascular intervention on the symptomatic leg within 6 months before enrollment, as per physician's discretion.
- •Participants with a baseline 6MWT of less than 152.0 meters (498ft) or greater than 487.7 meters (1600ft).
- •Known allergy to L-carnosine.
- •Participants with rare autosomal recessive metabolic disorder carnosinemia or carnosinase deficiency.
- •Currently participating in other clinical trials.
- •Participation in any carnosine supplementation clinical trial anytime in the past.
- •Participants already taking carnosine.
- •Participants unable to provide urine sample (anuric).
- •Pregnant participants.
- •Participants using dual antiplatelet therapies will not be included for biopsy.
- •Participants with internal metallic objects in body will not be eligible for MRI or 1HMRS.
研究组 & 干预措施
Carnosine
Carnosine 2 g daily for 6 months
干预措施: Carnosine (Drug)
结局指标
主要结局
Measure distance covered on six-minute walk test (6MWT)
时间窗: Baseline, 3 months, 6 months, 9 months
Distance covered on a flat and hard surface in 6 minutes. Units: Feet
次要结局
- Measure Ankle-Brachial Index (ABI)(Baseline, 3 months, 6 months, 9 months)
- Treadmill Testing(Baseline, 3 months, 6 months)
- Skin Integrity(Baseline, 3 months, 6 months)
- Musculoskeletal Assessment(Baseline, 3 months, 6 months)
- Neuromuscular Assessment(Baseline, 3 months, 6 months)
- Balance Assessment(Baseline, 3 months, 6 months)
- Quality of life Questionnaire(Baseline, 3 months, 6 months, 9 months)
- Assessment of PAD Severity(Baseline, 3 months, 6 months, 9 months)
- Depressive Symptoms Questionnaire(Baseline, 3 months, 6 months, 9 months)
- 24-hour Dietary Recall(Baseline, 3 months, 6 months, 9 months)
- Daily Walking Ability(-7-Baseline, Day 90-97, Day 180-187, Day 270-277)
- Blood Collection and Analysis(Baseline, 3 months, 6 months, 9 months)
- Measurement of Carnosine in Blood and Urine(Baseline, 3 months, 6 months, 9 months)
- Measure Angiogenic Cell Population(Baseline, 3 months, 6 months, 9 months)
- Mitochondrial Abundance Measurements(Baseline, 3 months, 6 months, 9 months)
- Measurement of Carnosine in Muscle(Baseline, 6 months)
- Measurement of Blood Flow(Baseline, 6 months)
- Calf Muscle Biopsy(Baseline, 6 months)
研究者
Shahid Baba
Professor
University of Louisville