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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Dietary supplement: Curcumin; Dietary supplement: Placebo comparator; Dietary supplement: Turmeric powder

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: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle Upon-Tyne, Tyne and Wear, United Kingdom, ne1 7RU
      • NU-Food

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline DNA methylation analyses based on the Illumina EPIC array	Baseline and 6 weeks post dose
Change from baseline oxidative stress determination using whole-blood chemiluminescence assays	Baseline and 6 weeks post dose

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: University College, London; University of Leeds; British Broadcasting Corporation; PB Biosystems Ltd

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Curcumin
• Other Study ID Numbers: NUHEALTH-KB01-TACT