Nucleophilic Defense Against PM Toxicity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 1
- 主要终点
- Endothelial Progenitor Cells
研究概览
简要总结
Carnosine is a naturally occurring peptide found in high levels in skeletal muscle and the brain and is also available commercially as a dietary supplement. Since carnosine has anti-oxidant properties and air pollution exposure induces a state of oxidative stress, the purpose of this study is to see if those taking carnosine as a dietary supplement are protected from air pollution-induced oxidative stress and adverse cardiovascular outcomes.
详细描述
This is a placebo controlled, randomized, double-blind, interventional trial investigating the efficacy of carnosine in reducing the effects of particulate matter air pollution (PM2.5). A total of 240 participants from the Louisville metropolitan and neighboring areas will be randomized into two dietary supplement study groups - carnosine (n=120) versus placebo (n=120). Intervention of study dietary supplements will occur from May through September, when the levels of PM2.5.are highest in the Louisville, KY area. Study participants will be given a daily oral dose of total of 2 grams of carnosine (or placebo) for a total of 12 consecutive weeks (during May through September).
Urinary levels of carnosine will be used to screen and identify potential candidates with low carnosine levels. Those with levels less than the median levels of the population, will be invited to participate in the study. The following measurements will be performed - blood and urine sample collection, physical examination, arterial stiffness, physical function, and self-reported surveys on environmental exposure, sleep, diet, and exercise. Supplement intervention (carnosine or placebo) will be initiated at the time of Baseline Assessment and will continue for 12 weeks from that date. Two follow up visits will occur at 6 weeks and 12 weeks respectively after initiating supplementation.
This innovative clinical investigation will provide an insight into the pre and post intervention effects of a cheap, safe, and over-the-counter available dietary supplement in countering the effects of air pollution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind (participant, investigator)
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between 22-65 years of age of either gender and all ethnicities,
- •All genders and all ethnicities
- •Residing in or near the Louisville metropolitan area
- •Consumes some type of meat/fish at least once a month during the past 3 months
- •Carnosine levels below the median level of the population
- •Agrees to complete all study visits and follow study intervention regimen
- •Will be living in the study area throughout the study period, with no more than 1 week away from the study area.
排除标准
- •Consumed any dietary supplement more than 3 times per week in the past 4 weeks (one month)
- •Current / ongoing treatment for substance abuse
- •Currently undergoing treatment or have conditions which may cause participant to be immunosuppressed
- •Diseases Affecting Peripheral Cell Count (i.e. Autoimmune Diseases - Hashimoto, Rheumatoid Arthritis, SLE, Rheumatoid Arthritis, Sjogren syndrome, Ankylosing Spondylitis, Takayasu arteritis, Kawasaki disease, Polyarteritis nodosa.)
- •Diseases Affecting Bone Marrow capacity
- •Diagnosis of any active cancer
- •Recent organ / kidney transplant or replacement (Active/Long-Term Medications)
- •Type 1 Diabetes Mellitus
- •Untreated thyroid disease
- •Untreated anemia
- •Current acute infections (Influenza, fever, etc.)
- •HIV positive status
- •Active/current Hepatitis HepA, HepB or HepC or in past 6 months
- •Currently or planning to be Pregnant / lactating
- •Prisoners / vulnerable populations
- •Other medical conditions that compromise completion of study
- •Unwilling to provide consent
研究组 & 干预措施
intervention group
Each participant will be given a daily oral dose of 2 grams of carnosine for 12 weeks
干预措施: L-carnosine (Dietary Supplement)
placebo group
Each participant will be given a daily oral dose of 2 grams of placebo for 12 weeks
干预措施: placebo (Other)
结局指标
主要结局
Endothelial Progenitor Cells
时间窗: 3 months
circulating pro-angiogenic cells
次要结局
- Endothelial Microparticles(Samples were collected from each participant at baseline, after ~6wk of intervention, and after ~12wk of intervention. Measurement will be performed on archived samples once assay is in place.)
- Augmentation Index(3 months)
- Platelet Monocyte Aggregates(3 months)
研究者
Timothy Edward O'Toole
Associate Professor
University of Louisville