Effects of wholegrain components on metabolic biomarkers: a four-week intervention study in 'at risk' subjects
| ISRCTN | ISRCTN93336504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93336504 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/09/2008
- Registration date
- 04/12/2008
- Last edited
- 05/07/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robert Welch
Scientific
Scientific
Northern Ireland Centre for Food and Health (NICHE)
Biomedical Sciences
University of Ulster
Cromore Road
Coleraine
BT52 1SA
United Kingdom
| Phone | +44 (0)28 7032 4205 |
|---|---|
| rw.welch@ulster.ac.uk |
Study information
| Study design | Single centre randomised single blind parallel controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| 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 | |
| Study objectives | 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(s) | The study was approved by the University of Ulster Research Ethics Committee in March 2007 (ref: REC/07/0016). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bran-rich cereal products |
| Primary outcome measure | 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 study start date | 15/12/2007 |
| Completion date | 04/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 volunteers (40 males; 40 females); 40 controls, 40 on test treatment |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/12/2007 |
| Date of final enrolment | 04/06/2008 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Northern Ireland Centre for Food and Health (NICHE)
Coleraine
BT52 1SA
United Kingdom
BT52 1SA
United Kingdom
Sponsor information
European Commission (Belgium)
Government
Government
Rue de la Loi, 200
Brussels
B-1049
Belgium
| Phone | +32 (0)2 295 08 57 |
|---|---|
| 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 European Union (EU) project (ref: FOOD-CT-2005-514008)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/11/2012 | Yes | No |
