Turmeric Anti-Inflammatory and Cell-Damage Trial | NCT02815475

Studies
Turmeric Anti-Inflammatory and Cell-Damage Trial

NCT02815475

Sponsor

Newcastle University

Status

Completed

Last Update Posted

Sep 9, 2016Estimated

Enrollment

90Actual

Phase

Not Applicable

Conditions

Healthy Adults

Interventions

Placebo comparator
Curcumin
Turmeric powder

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jun 20, 2016

First Submission Date that Met QC Criteria

Jun 23, 2016

First Posted Date

Jun 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 8, 2016

Last Update Posted Date

Sep 9, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Anthony Watson, Research Associate, Newcastle UniversityPrincipal Investigator

Lead Sponsor

Newcastle UniversityOTHER

Collaborators

Name	Class
British Broadcasting Corporation	INDUSTRY
University College, London	OTHER
University of Leeds	OTHER
PB Biosystems Ltd

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Placebo comparator	Dietary Supplement		Placebo
Curcumin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NU-Food		Newcastle upon Tyne	Tyne and Wear	ne1 7RU	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D003474	Curcumin

Ancestor Terms

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

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