Turmeric Anti-Inflammatory and Cell-Damage Trial (TACT)

Newcastle University

Status: Completed

Conditions: Healthy Adults

Treatments: Dietary Supplement: Turmeric powder; Dietary Supplement: Placebo comparator; Dietary Supplement: Curcumin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02815475

NUHEALTH-KB01-TACT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Starch filled capsule

Treatment:

Dietary Supplement: Placebo comparator

Curcumin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Curcumin

Turmeric powder

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Turmeric powder