NCT02815475

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

5 months

First QC Date

June 20, 2016

Last Update Submit

September 8, 2016

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

  • Change from baseline DNA methylation analyses based on the Illumina EPIC array

    Baseline and 6 weeks post dose

  • Change from baseline oxidative stress determination using whole-blood chemiluminescence assays

    Baseline and 6 weeks post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Starch filled capsule

Dietary Supplement: Placebo comparator

Curcumin

EXPERIMENTAL

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

Dietary Supplement: Curcumin

Turmeric powder

ACTIVE COMPARATOR

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

Dietary Supplement: Turmeric powder

Interventions

Placebo comparatorDIETARY_SUPPLEMENT
Placebo
CurcuminDIETARY_SUPPLEMENT
Curcumin
Turmeric powderDIETARY_SUPPLEMENT
Turmeric powder

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years and over
  • No pre-existing medical conditions
  • not currently taking prescribed drugs or over the counter supplements
  • Male and female

You may not qualify if:

  • Any pre-existing medical condition
  • Taking prescribed drugs or over the counter supplements
  • Aged 17 years or under
  • BMI \> 40mg/m2
  • BP \> 160/120

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NU-Food

Newcastle upon Tyne, Tyne and Wear, ne1 7RU, United Kingdom

Location

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 28, 2016

Study Start

March 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations

GB(1)