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Turmeric Anti-Inflammatory and Cell-Damage Trial

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赞助商
Newcastle University
合作者
British Broadcasting Corporation
University College, London
University of Leeds
PB Biosystems Ltd

关键词

抽象

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.

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.

日期

最后验证: 08/31/2016
首次提交: 06/19/2016
提交的预估入学人数: 06/22/2016
首次发布: 06/27/2016
上次提交的更新: 09/07/2016
最近更新发布: 09/08/2016
实际学习开始日期: 02/29/2016
预计主要完成日期: 07/31/2016
预计完成日期: 07/31/2016

状况或疾病

Healthy Adults

干预/治疗

Dietary Supplement: Placebo

Dietary Supplement: Curcumin

Dietary Supplement: Turmeric powder

-

手臂组

干预/治疗
Placebo Comparator: Placebo
Starch filled capsule
Dietary Supplement: Placebo
Experimental: Curcumin
400mg of Curcumin via capsule to be consumed every other day
Dietary Supplement: Curcumin
Active Comparator: Turmeric powder
2 teaspoons of dried turmeric powder to be consumed every other day
Dietary Supplement: Turmeric powder

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

Inclusion Criteria:

- Aged 18 years and over

- No pre-existing medical conditions

- not currently taking prescribed drugs or over the counter supplements

- Male and female

Exclusion Criteria:

- Any pre-existing medical condition

- Taking prescribed drugs or over the counter supplements

- Aged 17 years or under

- BMI > 40mg/m2

- BP > 160/120

结果

主要结果指标

1. Change from baseline DNA methylation analyses based on the Illumina EPIC array [Baseline and 6 weeks post dose]

2. Change from baseline oxidative stress determination using whole-blood chemiluminescence assays [Baseline and 6 weeks post dose]

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