Clinical trial NCT02177279: Bioactive Phytochemicals From Wheat Bran
Official title: Identification of Novel Bioactive Compounds in Wheat Bran
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bio-availability of Wheat Bran Phytochemicals in the Human Gut
Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation
Keywords: Wheat bran cereals, bran phytochemicals, phytochemicals bioavailability
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: Kellogg Company
First posted: 2014-06-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Human bioavailability of benzoic acids and derivatives from wheat bran cereals
timeFrame: over 24 h
measure: Human bioavailability of cinnamic acids and derivatives from wheat bran cereals
timeFrame: over 24h
measure: Human bioavailability of phenylpropanoid dimers from wheat bran cereals
timeFrame: over 24h
measure: Human bioavailability of phenyl propionic acids from wheat bran cereals
timeFrame: over 24h
measure: Bioavailability of benzaldehydes from wheat bran
timeFrame: over 24h
measure: Human bioavailability of acetophenones from wheat bran cereals
timeFrame: over 24h
measure: Human bioavailability of lignans from wheat bran cereals
timeFrame: over 24 h
measure: Short chain fatty acids profile after wheat bran consumption (acute)
timeFrame: 24 h
measure: Short chain fatty acids profile after wheat bran consumption (chronic)
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Rowett Institute of Nutrition and Health, University of Aberdeen
state: Aberdeenshire
Study officials:
affiliation: Rowett Institute of Nutrition and Health, University of Aberdeen
name: Wendy R Russell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rowett Institute of Nutrition and Health, University of Aberdeen
name: Baukje de Roos, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rowett Institute of Nutrition and Health, University of Aberdeen
name: Garry Duthie, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Kellogg Company
name: Jolene McMonagle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kellogg Company
name: Reg Fletcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: