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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

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.

Condition or disease Intervention/treatment Phase
Healthy Adults Dietary Supplement: Placebo comparator Dietary Supplement: Curcumin Dietary Supplement: Turmeric powder Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Turmeric Anti-Inflammatory and Cell-Damage Trial
Study Start Date : March 2016
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Starch filled capsule
Dietary Supplement: Placebo comparator
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



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815475


Locations
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United Kingdom
NU-Food
Newcastle Upon-Tyne, Tyne and Wear, United Kingdom, ne1 7RU
Sponsors and Collaborators
Newcastle University
British Broadcasting Corporation
University College, London
University of Leeds
PB Biosystems Ltd
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Responsible Party: Anthony Watson, Research Associate, Newcastle University
ClinicalTrials.gov Identifier: NCT02815475    
Other Study ID Numbers: NUHEALTH-KB01-TACT
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: September 9, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action