Turmeric Anti-Inflammatory and Cell-Damage Trial

NCT ID: NCT02815475

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Starch filled capsule

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

Curcumin

400mg of Curcumin via capsule to be consumed every other day

Group Type EXPERIMENTAL

Curcumin

Intervention Type DIETARY_SUPPLEMENT

Turmeric powder

2 teaspoons of dried turmeric powder to be consumed every other day

Group Type ACTIVE_COMPARATOR

Turmeric powder

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

Curcumin

Intervention Type DIETARY_SUPPLEMENT

Turmeric powder

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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British Broadcasting Corporation

INDUSTRY

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role collaborator

University of Leeds

OTHER

Sponsor Role collaborator

PB Biosystems Ltd

UNKNOWN

Sponsor Role collaborator

Newcastle University

OTHER

Sponsor Role lead

Responsible Party

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Anthony Watson

Research Associate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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NU-Food

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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NUHEALTH-KB01-TACT

Identifier Type: -

Identifier Source: org_study_id

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