Condition category
Nutritional, Metabolic, Endocrine
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 from bread rolls

Acronym

Study hypothesis

Bioactive components present in processed wheat grain fraction enriched bread rolls are available to the body and can be detected in the plasma and urine shortly after consumption.

Ethics approval

University of Ulster Research Ethics Committee, May 2006, ref: REC/06/0036

Study design

Randomised within subject 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

Prevention

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 aleurone incorporated into a bread roll
2. Test-meal 2: 50 g wheat aleurone + 5.2 mg iron incorporated into a bread roll
3. Control-meal: 50 g refined wheat product incorporated into a bread roll

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

Intervention type

Drug

Phase

Not Specified

Drug names

Wheat grain

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
3. Evaluation of the effects of processing, including iron fortification, on the availability of the bioactive components in wheat fractions, using test-meal 2 and comparisons with previous work

Overall trial start date

01/01/2007

Overall trial end date

31/03/2007

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

13 (6 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 4 months prior to the study

Recruitment start date

01/01/2007

Recruitment end date

31/03/2007

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 EU project (ref: FOOD-CT-2005-514008)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

Intention to publish date

31/12/2013

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25585164

Publication citations

Additional files

Editorial Notes

04/03/2016: No publications found, verifying study status with principal investigator.