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临床试验/NCT02815475
NCT02815475已完成不适用

Turmeric Anti-Inflammatory and Cell-Damage Trial

Newcastle University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2016年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change from baseline DNA methylation analyses based on the Illumina EPIC array

研究概览

简要总结

This trial will be conducted for the BBC. The aim of the project is to assess if consuming the spice turmeric every other day, in the amount consumed in a curry, can reduce cell damage and inflammation. The results of the project will be used to inform the TV program Trust Me I'm a Doctor.

详细描述

100 volunteers will be recruited for a 6 week intervention. The study group will be divided into 3 arms, each with approximately. 33 participants; one arm will receive a placebo capsule, one arm will receive a capsule with 400mg of curcumin (corresponding to two teaspoons of turmeric powder). These treatments are done double-blind. A third arm is 'open label', these volunteers will receive a bag with at least 135g turmeric and be asked to add two teaspoon to their food. Participants will be asked to supplement their diet with turmeric (powder, capsule or placebo) every other day for six weeks.

Participants will be asked to attend the NU-Food research facility on 3 occasions. The first will be a screening session where participants will be given the option to discuss the project with a researcher. Participants will complete a screening questionnaire and sign an informed consent form. On the next visit, participants will arrive at the research facility at a pre-arranged time and firstly have their height and weight measured. Participants will then give 10ml of blood via venepuncture and asked to provide a 10ml spot urine sample. After this participants will be randomly allocated a treatment group (placebo, turmeric capsule or turmeric powder) and given instructions on dosage. After a 6 week treatment period, participants will return to the research facility, have their height and weight measured then give a second 10ml venous blood sample and provide a final spot urine sample. Each visit will take around 20 minutes.

The main outcomes of the trial are oxidative stress and inflammation tests which will be conducted by PB bioscience and an assessment of DNA methylation by University College London. Proteomics analysis will be conducted on Urine samples.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years and over
  • No pre-existing medical conditions
  • not currently taking prescribed drugs or over the counter supplements
  • Male and female

排除标准

  • Any pre-existing medical condition
  • Taking prescribed drugs or over the counter supplements
  • Aged 17 years or under
  • BMI > 40mg/m2
  • BP > 160/120

结局指标

主要结局

Change from baseline DNA methylation analyses based on the Illumina EPIC array

时间窗: Baseline and 6 weeks post dose

Change from baseline oxidative stress determination using whole-blood chemiluminescence assays

时间窗: Baseline and 6 weeks post dose

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

Anthony Watson

Research Associate

Newcastle University

研究点 (2)

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