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OpenTrials
Completed

NCT Number: NCT02177279

Bioactive Phytochemicals From Wheat Bran

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.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rowett Institute of Nutrition and Health, University of Aberdeen

Aberdeen, Aberdeenshire, AB21 9SB, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visit A high wheat bran

Other

Visit B normal wheat bran

Other

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

Other

Primary outcomes

  1. Human bioavailability of benzoic acids and derivatives from wheat bran cereals

    Time frame: over 24 h

    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).

  2. Human bioavailability of cinnamic acids and derivatives from wheat bran cereals

    Time frame: over 24h

    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).

  3. Human bioavailability of phenylpropanoid dimers from wheat bran cereals

    Time frame: over 24h

    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).

  4. Human bioavailability of phenyl propionic acids from wheat bran cereals

    Time frame: over 24h

    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).

  5. Bioavailability of benzaldehydes from wheat bran

    Time frame: over 24h

    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).

  6. Human bioavailability of acetophenones from wheat bran cereals

    Time frame: over 24h

    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).

  7. Human bioavailability of lignans from wheat bran cereals

    Time frame: over 24 h

    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).

  8. Short chain fatty acids profile after wheat bran consumption (acute)

    Time frame: 24 h

    Short chain fatty acids profile in faecal samples at 0h (baseline) and 24h after wheat bran consumption (40g and 120g).

  9. Short chain fatty acids profile after wheat bran consumption (chronic)

    Time frame: 9 days

    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).

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • Kellogg Company

Registry information

Official study title

Identification of Novel Bioactive Compounds in Wheat Bran

Acronym: WB2001

Important dates

Study start
2011
Primary completion
2013
First posted
Jun 27, 2014
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.