Evaluation of the bioavailability of bioactive wheat bran components
| ISRCTN | ISRCTN09560399 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN09560399 |
| 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
- 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 Rd
Coleraine
BT52 1SA
United Kingdom
| Phone | +44 (0)28 7032 4205 |
|---|---|
| rw.welch@ulster.ac.uk |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Diagnostic |
| 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 |
| Study objectives | 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(s) | The study was approved by the University of Ulster Research Ethics Committee in July 2006 (ref: REC/06/0012). |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bioactive wheat bran |
| 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 |
| Overall study start date | 01/04/2006 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 14 (7 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 6 months prior to the study |
| Date of first enrolment | 01/04/2006 |
| Date of final enrolment | 31/05/2006 |
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 | 17/02/2016 | Yes | No |
Editorial Notes
04/03/2016: Publication reference added.
