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Completed

NCT Number: NCT02815475

Turmeric Anti-Inflammatory and Cell-Damage Trial

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.

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Key information

Conditions

Healthy Adults

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NU-Food

Newcastle upon Tyne, Tyne and Wear, ne1 7RU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Comparator

Dietary Supplement

Curcumin

Dietary Supplement

Turmeric powder

Dietary Supplement

Primary outcomes

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

    Time frame: Baseline and 6 weeks post dose

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

    Time frame: Baseline and 6 weeks post dose

Sponsors and collaborators

Lead sponsor

Newcastle University

Other

Collaborators

  • British Broadcasting Corporation
  • PB Biosystems Ltd
  • University College, London
  • University of Leeds

Registry information

Acronym: TACT

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 28, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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