Turmeric Anti-Inflammatory and Cell-Damage Trial (TACT)
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|ClinicalTrials.gov Identifier: NCT02815475|
Recruitment Status : Completed
First Posted : June 28, 2016
Last Update Posted : September 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy Adults||Dietary Supplement: Placebo comparator Dietary Supplement: Curcumin Dietary Supplement: Turmeric powder||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Turmeric Anti-Inflammatory and Cell-Damage Trial|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Placebo Comparator: Placebo
Starch filled capsule
Dietary Supplement: Placebo comparator
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
- Change from baseline DNA methylation analyses based on the Illumina EPIC array [ Time Frame: Baseline and 6 weeks post dose ]
- Change from baseline oxidative stress determination using whole-blood chemiluminescence assays [ Time Frame: Baseline and 6 weeks post dose ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815475
|Newcastle Upon-Tyne, Tyne and Wear, United Kingdom, ne1 7RU|