Turmeric Anti-Inflammatory and Cell-Damage Trial

Healthy Adults Clinical Trial

— TACT  

Official title:

Turmeric Anti-Inflammatory and Cell-Damage Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02815475
• Other study ID #: NUHEALTH-KB01-TACT
• Status: Completed
• Phase: N/A
• First received: June 20, 2016
• Last updated: September 8, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Newcastle University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Dietary Supplement:
• Placebo comparator

• Curcumin

• Turmeric powder

Locations

Country	Name	City	State
United Kingdom	NU-Food	Newcastle Upon-Tyne	Tyne and Wear

Sponsors (5)

Lead Sponsor	Collaborator
Newcastle University	British Broadcasting Corporation, PB Biosystems Ltd, University College, London, University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline DNA methylation analyses based on the Illumina EPIC array		Baseline and 6 weeks post dose	No
Primary	Change from baseline oxidative stress determination using whole-blood chemiluminescence assays		Baseline and 6 weeks post dose	No