Bioactive Phytochemicals From Wheat Bran

NCT ID: NCT02177279

Last Updated: 2014-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bio-availability of Wheat Bran Phytochemicals in the Human Gut Bio-availability of Wheat Bran Phytochemicals for the Systemic Circulation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Visit A- 120g wheat bran cereals

A morning vist where volunteers consumed 120g of wheat bran cereals with 125ml semi-skimmed milk

Group Type OTHER

Visit A high wheat bran

Intervention Type OTHER

Visit B-40g wheat bran cereals

A morning vist where volunteers consumed 40g of wheat bran cereals with 375 ml semi-skimmed milk

Group Type OTHER

Visit B normal wheat bran

Intervention Type OTHER

Follow up-40g (8days), 120g (1day) wheat bran cereals

Volunteers follow their normal diet but they were asked to consume 40g wheat bran cereals with 125 ml semi-skimmed milk for eight days and on day nine 120g wheat bran cereals with 375ml semi-skimmed milk

Group Type OTHER

Follow up normal (8days) and high (1day) bran consumption

Intervention Type OTHER

Interventions

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Visit A high wheat bran

Intervention Type OTHER

Visit B normal wheat bran

Intervention Type OTHER

Follow up normal (8days) and high (1day) bran consumption

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kellogg Company

INDUSTRY

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wendy R Russell, PhD

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute of Nutrition and Health, University of Aberdeen

Baukje de Roos, PhD

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute of Nutrition and Health, University of Aberdeen

Garry Duthie, Professor

Role: PRINCIPAL_INVESTIGATOR

Rowett Institute of Nutrition and Health, University of Aberdeen

Jolene McMonagle, PhD

Role: PRINCIPAL_INVESTIGATOR

Kellogg Company

Reg Fletcher, PhD

Role: PRINCIPAL_INVESTIGATOR

Kellogg Company

Locations

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Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, Aberdeenshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Wheat Bran 2001

Identifier Type: -

Identifier Source: org_study_id

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