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临床试验/NCT04497077
NCT04497077已完成不适用

Comparison of Acute Tart Cherry Supplement Formulation and Dose on Inflammation and Oxidative Capacity

Ohio University0 个研究点目标入组 48 人开始时间: 2015年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
主要终点
Change in c-reactive protein

研究概览

简要总结

A comparison of acute tart cherry formations (juice vs. powdered) and doses (single vs. twice daily) on inflammation and oxidative capacity.

详细描述

Participants will be randomly allocated to a group: one tart cherry capsule daily, two tart cherry capsules daily, one 8oz. bottle of tart cherry juice daily, two 8oz. bottles of tart cherry juice taken 8 hours apart, one placebo pill, and one 8oz. bottle of placebo. Participants will arrive to the lab at 8 am after an overnight fast of 10 hours. They will provide a blood sample and then ingest their study treatment. Participants will stay in the lab for a further 2 hours for additional blood draws then return to the lab in 6 hours for another blood draw. At this time if they are in a twice daily group they will receive their second treatment for the day. All participants will come back to the lab 24 hours later where they will give a blood sample and receive their next treatment. If they are in the twice daily group they will be provided with their next dose and given instructions to consume it in 8 hours. Participants will arrive 24 hours later for a final blood draw with no supplementation.

Blood samples will be measured pre-ingestion, 1 hour, 2 hours, 8 hours, 24 hours and 48 hours post-ingestion. Samples will be analyzed for plasma oxygen radical absorbance capacity (ORAC), uric acid (UA), and C-reactive protein (CRP).

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)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • free of cardiovascular, metabolic and inflammatory conditions
  • non-smokers
  • no known allergy to cherries or cherry juice
  • not be taking food supplements (turmeric/curcumin, cherry products, greens, etc.).

排除标准

  • quit smoking less than one year ago.
  • currently being treated for arthritis or an inflammatory condition.
  • currently being treated for uncontrolled cardiovascular disease, high blood pressure, diabetes, fibromyalgia, or irritable bowel syndrome.
  • pregnant.
  • regularly consume cherries or are allergic to cherries or dairy.
  • currently use anti-inflammatory medications,
  • have used corticosteroids in the last two months.

结局指标

主要结局

Change in c-reactive protein

时间窗: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion

c-reactive protein (mg/L) measured via assay

Change in oxidative capacity

时间窗: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion

oxygen radical absorbance capacity (uM Trolox equivalents) measured via assay

Change in uric acid

时间窗: 1 hour, 2 hours, 8 hours, 24 hours, and 48 hours post ingestion

uric acid (mg/dL) measured via assay

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Angela Hillman

Assistant Professor

Ohio University

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