Healthy Adults Clinical Trial
Official title:
Turmeric Anti-Inflammatory and Cell-Damage Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
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