Evaluation of the bioavailability of bioactive wheat bran components from bread rolls

ISRCTN	ISRCTN27269236
DOI	https://doi.org/10.1186/ISRCTN27269236
Secondary identifying numbers	N/A

Submission date: 17/09/2008
Registration date: 04/12/2008
Last edited: 04/03/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Robert Welch
Scientific

Northern Ireland Centre for Food and Health (NICHE)
Biomedical Sciences
University of Ulster
Cromore Rd
Coleraine
BT52 1SA
United Kingdom

Phone	+44 (0)28 7032 4205
Email	rw.welch@ulster.ac.uk

Study information

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
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Evaluation of the bioavailability of bioactive wheat bran components from bread rolls
Study objectives	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(s)	University of Ulster Research Ethics Committee, May 2006, ref: REC/06/0036
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Wheat grain
Primary outcome measure	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 study start date	01/01/2007
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	13 (6 males; 7 females)
Key inclusion criteria	Healthy 18 - 40 year old men and women with Body Mass Index (BMI) between 18 and 30 kg/m^2.
Key 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
Date of first enrolment	01/01/2007
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

Northern Ireland
United Kingdom

Study participating centre

Northern Ireland Centre for Food and Health (NICHE)

Coleraine
BT52 1SA
United Kingdom

Sponsor information

European Commission (Belgium)
Government

Rue de la Loi, 200
Brussels
B-1049
Belgium

Phone	+32 (0)2 295 08 57
Email	Daniele.Tissot@ec.europa.eu
Website	http://www.healthgrain.org
"ROR"	https://ror.org/00k4n6c32

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date	31/12/2013
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Planned publication in a peer reviewed journal.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	14/02/2015		Yes	No

Editorial Notes

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