Condition category
Not Applicable
Date applied
03/09/2008
Date assigned
04/12/2008
Last edited
05/07/2012
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 Road
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

Acronym

Study hypothesis

Long-term consumption of bran-rich cereal products impacts favourably on risk factors for heart disease and metabolic syndrome in apparently healthy, 'at risk' men and women.

Ethics approval

The study was approved by the University of Ulster Research Ethics Committee in March 2007 (ref: REC/07/0016).

Study design

Single centre randomised single blind parallel controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

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

Volunteers were stratified by age and sex and randomly assigned into the test or control group:
1. Test group: 3 x high-bran products per day for 4 weeks (1 x ready-to-eat cereal + 2 x bread products)
2. Control group: 3 x refined high-fibre products per day for 4 weeks (1 x ready-to-eat cereal + 2 x bread products)

Test and control products were balanced for energy, fibre and macronutrients and incorporated by volunteers into their normal diet.

Intervention type

Drug

Phase

Not Specified

Drug names

Bran-rich cereal products

Primary outcome measures

Changes in plasma homocysteine (a risk marker for CHD) attributable to treatment during the intervention, measured at baseline and 4 weeks.

Secondary outcome measures

Changes in other risk markers for disease attributable to treatments during the intervention:
1. Inflammatory markers and endothelial function
2. Antioxidant status
3. Lipid profile
4. Relevant micronutrient levels
5. Insulin and glucose levels

Outcomes measured at baseline and 4 weeks.

Overall trial start date

15/12/2007

Overall trial end date

04/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy men and women aged between 45 - 65 years
2. Body Mass Index (BMI) greater than 25 kg/m^2

This inclusion criteria were selected as such individuals are thought to be at a slightly greater risk of chronic disease.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 volunteers (40 males; 40 females); 40 controls, 40 on test treatment

Participant exclusion criteria

1. Smokers
2. People on special diets (e.g. vegetarians, coeliac patients)
3. People with diabetes
4. Pre-existing chronic disease
5. Regular use of prescription medicine, including statins and blood pressure medication
6. People who regularly take any vitamin or mineral supplement or have done so in the last 6 months
7. Women who are pregnant or lactating
8. People who have given blood to the blood transfusion service (BTS) within the past 4 months

Recruitment start date

15/12/2007

Recruitment end date

04/06/2008

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/22243564

Publication citations

  1. Results

    Price RK, Wallace JM, Hamill LL, Keaveney EM, Strain JJ, Parker MJ, Welch RW, Evaluation of the effect of wheat aleurone-rich foods on markers of antioxidant status, inflammation and endothelial function in apparently healthy men and women., Br. J. Nutr., 2012, 108, 9, 1644-1651, doi: 10.1017/S0007114511007070.

Additional files

Editorial Notes