Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation Clinical Trial
— WB2001Official title:
Identification of Novel Bioactive Compounds in Wheat Bran
| NCT number | NCT02177279 |
| Other study ID # | Wheat Bran 2001 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | June 19, 2014 |
| Last updated | July 7, 2014 |
| Start date | December 2011 |
| Verified date | July 2014 |
| Source | University of Aberdeen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: National Health Service |
| Study type | Interventional |
There is a lot of evidence to suggest that eating a diet rich in cereals such as wheat bran
are beneficial in protecting us from diseases such as heart disease, diabetes and cancer. It
is still not clear exactly why this happens, but it is likely that the compounds which enter
our bodies when we eat such products are responsible. In this study we plan to find out what
these compounds are and where they are found. The investigators will do this by asking
volunteers to eat a wheat-bran meal and then measuring the compounds that appear in blood,
urine and stool samples over the next twenty-four hours. Once the investigators know how
much and which compounds are present, we can then find out possible reasons why they are
protective, for example by looking to see whether they are anti-inflammatory. We also plan
to look at whether if having a diet which contains either a lot of wheat-bran products or
very low amounts of these foods effects how they are absorbed by the body.
HYPOTHESIS: Wheat bran from ready-to-eat cereal has unique phytochemical profiles which are
metabolized to compounds responsible for high cellular bioactivity imparting important
health benefits.
| Status | Completed |
| Enrollment | 8 |
| Est. completion date | |
| Est. primary completion date | February 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Volunteers will be healthy males or females and aged between 18 and 55 years who have a documented low (less than 1 portion per week) or high (more than or equal 5 portions per week) consumption of wheat bran and are able to give informed consent. Exclusion Criteria: - are taking any medicines prescribed by their general practitioner - are taking drugs to lower high cholesterol levels or high blood pressure - regularly take analgesics, antipyretic or anti-inflammatories - regularly take nutritional supplements - have taken antibiotics in the last three months - have given a large blood donation in last three months |
Allocation: Non-Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Rowett Institute of Nutrition and Health, University of Aberdeen | Aberdeen | Aberdeenshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aberdeen | Kellogg's |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Human bioavailability of benzoic acids and derivatives from wheat bran cereals | The analysis of the benzoic acid and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24 h | No |
| Primary | Human bioavailability of cinnamic acids and derivatives from wheat bran cereals | The analysis of the cinnamic acids and derivatives metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | No |
| Primary | Human bioavailability of phenylpropanoid dimers from wheat bran cereals | The analysis of the phenylpropanoid dimers metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | No |
| Primary | Human bioavailability of phenyl propionic acids from wheat bran cereals | The analysis of the phenyl propionic acids metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | No |
| Primary | Bioavailability of benzaldehydes from wheat bran | The analysis of the benzaldehydes metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | No |
| Primary | Human bioavailability of acetophenones from wheat bran cereals | The analysis of the acetophenones metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24h | No |
| Primary | Human bioavailability of lignans from wheat bran cereals | The analysis of the lignans metabolites in blood, urine, faecal samples after consumption of 40g and 120g wheat bran cereals, over 24 h period (change from baseline time 0h). | over 24 h | No |
| Primary | Short chain fatty acids profile after wheat bran consumption (acute) | Short chain fatty acids profile in faecal samples at 0h (baseline) and 24h after wheat bran consumption (40g and 120g). | 24 h | No |
| Primary | Short chain fatty acids profile after wheat bran consumption (chronic) | Short chain fatty acids profile in in faecal samples at day 0 (baseline), day 5 (during 7 days consumption of 40g wheat bran cereals/day) and day 10 (after 120g wheat bran cereals consumption on day 9). | 9 days | No |