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Turmeric Anti-Inflammatory and Cell-Damage Trial (TACT)

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ClinicalTrials.gov Identifier: NCT02815475
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : September 9, 2016
Sponsor:
Collaborators:
British Broadcasting Corporation
University College, London
University of Leeds
PB Biosystems Ltd
Information provided by (Responsible Party):
Anthony Watson, Newcastle University

Tracking Information
First Submitted Date  ICMJE June 20, 2016
First Posted Date  ICMJE June 28, 2016
Last Update Posted Date September 9, 2016
Study Start Date  ICMJE March 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2016)
  • Change from baseline DNA methylation analyses based on the Illumina EPIC array [ Time Frame: Baseline and 6 weeks post dose ]
  • Change from baseline oxidative stress determination using whole-blood chemiluminescence assays [ Time Frame: Baseline and 6 weeks post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Turmeric Anti-Inflammatory and Cell-Damage Trial
Official Title  ICMJE Turmeric Anti-Inflammatory and Cell-Damage Trial
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Dietary Supplement: Placebo comparator
  • Dietary Supplement: Curcumin
  • Dietary Supplement: Turmeric powder
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Starch filled capsule
    Intervention: Dietary Supplement: Placebo comparator
  • Experimental: Curcumin
    400mg of Curcumin via capsule to be consumed every other day
    Intervention: Dietary Supplement: Curcumin
  • Active Comparator: Turmeric powder
    2 teaspoons of dried turmeric powder to be consumed every other day
    Intervention: Dietary Supplement: Turmeric powder
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 8, 2016)
90
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2016)
100
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02815475
Other Study ID Numbers  ICMJE NUHEALTH-KB01-TACT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Watson, Newcastle University
Study Sponsor  ICMJE Newcastle University
Collaborators  ICMJE
  • British Broadcasting Corporation
  • University College, London
  • University of Leeds
  • PB Biosystems Ltd
Investigators  ICMJE Not Provided
PRS Account Newcastle University
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP