Condition category
Not Applicable
Date applied
17/09/2008
Date assigned
04/12/2008
Last edited
04/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.healthgrain.org

Contact information

Type

Scientific

Primary contact

Prof Robert Welch

ORCID ID

Contact details

Northern Ireland Centre for Food and Health (NICHE)
Biomedical Sciences
University of Ulster
Cromore Rd
Coleraine
BT52 1SA
United Kingdom
+44 (0)28 7032 4205
rw.welch@ulster.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Evaluation of the bioavailability of bioactive wheat bran components

Acronym

Study hypothesis

Bioactive components present in minimally processed wheat grain fractions are available to the body and can be detected in the plasma and urine shortly after consumption.

Ethics approval

The study was approved by the University of Ulster Research Ethics Committee in July 2006 (ref: REC/06/0012).

Study design

Randomised cross-over design on three occasions carried out in a single-centre

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic diseases, particularly cardiovascular disease and cancers

Intervention

1. Test-meal 1: 50 g wheat bran boiled in water with sugar
2. Test-meal 2: 50 g wheat aleurone boiled in water with sugar
3. Control-meal: 50 g refined wheat product

Test and control meals were balanced for energy, fibre and macronutrients.

Intervention type

Drug

Phase

Not Specified

Drug names

Bioactive wheat bran

Primary outcome measures

1. Changes in plasma betaine, choline, folate, tocopherols and ferulic acid attributable to treatments, measured at baseline, 0.5 hours, 1 hour, 2 hours and 3 hours post-meal
2. Changes in urinary ferulic acid attributable to treatments, measured at baseline, 0.5 hours, 1 hour, 2 hours, 3 hours and 4 hours post-meal

Secondary outcome measures

1. Changes in plasma antioxidant activity attributable to treatments, measured at baseline, 0.5 hours, 1 hour, 2 hours and 3 hours post-meal
2. Changes in urinary antioxidant activity and phenolic activity attributable to treatments, measured at baseline, 0.5 hours, 1 hour, 2 hours, 3 hours and 4 hours post-meal

Overall trial start date

01/04/2006

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy 18 - 40 year old men and women with Body Mass Index (BMI) between 18 and 30 kg/m^2.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

14 (7 males; 7 females)

Participant exclusion criteria

1. Smokers
2. Individuals with diabetes
3. Pre-existing chronic disease
4. On any prescription medicine
5. Individuals who regularly take any vitamin or mineral supplement or did so in the 6 months prior to the study
6. Gluten or wheat intolerant individuals
7. Pregnant or lactating women
8. Individuals who have given blood to the Blood Transfusion Service (BTS) in the 6 months prior to the study

Recruitment start date

01/04/2006

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern Ireland Centre for Food and Health (NICHE)
Coleraine
BT52 1SA
United Kingdom

Sponsor information

Organisation

European Commission (Belgium)

Sponsor details

Rue de la Loi
200
Brussels
B-1049
Belgium
+32 (0)2 295 08 57
Daniele.Tissot@ec.europa.eu

Sponsor type

Government

Website

http://www.healthgrain.org

Funders

Funder type

Government

Funder name

HEALTHGRAIN (Europe) - an integrated 6th framework European Union (EU) project (ref: FOOD-CT-2005-514008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/26901221

Publication citations

Additional files

Editorial Notes

04/03/2016: Publication reference added.