Clinical trial NCT02815475: Turmeric Anti-Inflammatory and Cell-Damage Trial
Official title: Turmeric Anti-Inflammatory and Cell-Damage Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Newcastle University
Sponsor class: OTHER
Collaborators: name: British Broadcasting Corporation
name: University College, London
name: University of Leeds
name: PB Biosystems Ltd
First posted: 2016-06-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline DNA methylation analyses based on the Illumina EPIC array
timeFrame: Baseline and 6 weeks post dose
measure: Change from baseline oxidative stress determination using whole-blood chemiluminescence assays
timeFrame: Baseline and 6 weeks post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle Upon-Tyne
country: United Kingdom
facility: NU-Food
state: Tyne and Wear
Study officials:
References: