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Completed

NCT Number: NCT02155062

Biomarkers of Whole Grain Wheat and Rye Intake

Alkylresorcinols (AR) are a group of lipids found in the bran fraction of wheat and rye grains. AR are absorbed into the bloodstream and their metabolites are excreted in urine in measurable amounts following ingestion of wholegrain (WG) wheat or rye cereal. As AR are absent in refined cereals, plasma AR and urinary AR metabolites are proposed as suitable biomarkers of dietary intake of WG wheat and rye cereal, with a number of studies supporting this proposal. Different AR species are present in characteristic quantities in WG wheat in comparison to WG rye cereals, which can allow identification of the main source of WG (wheat or rye) in individuals by analysing the AR concentrations in blood. However the patterns of urinary AR metabolite excretion following wheat or rye intake have not yet been investigated to determine if there are differences according to WG source.

The present study aims to:

(i) investigate the differences in AR metabolite excretion pattern in spot and 24 hour urine samples after following a predominantly WG rye-based diet in comparison to a predominantly WG wheat-based diet and in comparison to control (refined cereal diet) (ii) compare the validity and reproducibility of AR metabolites in spot urine samples in comparison to 24 hour urine samples.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes and Nutritional Sciences Division, King's College London

London, SW1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass intake 18.5-30.0 kg/m2
  • Weight stable for 2 months
  • Generally healthy

Exclusion criteria

  • Previous or current chronic disease including heart disease, diabetes, gastrointestinal, liver, renal or endocrine disorders
  • Drug or alcohol misuse in the last year
  • Current pregnancy or lactation
  • Weight change of >3 kg in the last two months
  • Current regular user of certain prescription medications (except contraceptives)
  • Unwilling to consume or to stop consuming WG wheat, WG rye or refined cereals
  • Unwilling to discontinue multivitamins/dietary supplements during study

Treatment and study plan

Whole grain rye

Other

Whole grain wheat

Other

Refined cereal

Other

Primary outcomes

  1. 24-h urinary DHBA:DHPPA ratio

    Time frame: Endpoint (Day 3)

    DHBA: 3,5-dihydroxybenzoic acid DHPPA: 3-(3,5-dihydroxyphenyl)-propanoic acid

    DHBA & DHPPA are the main AR metabolites excreted in urine

Secondary outcomes

  1. DHBA:DHPPA ratio in morning spot urine

    Time frame: Endpoint (Day 3)

  2. Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion

    Time frame: Endpoint (Day 3)

  3. Total 24-h urinary DHBA excretion

    Time frame: Endpoint (Day 3)

  4. Total 24-h urinary DHPPA excretion

    Time frame: Endpoint (Day 3)

  5. 24-h urinary total AR (DHBA+DHPPA):creatinine ratio

    Time frame: Endpoint (Day 3)

  6. 24-h urinary DHBA:creatinine ratio

    Time frame: Endpoint (Day 3)

  7. 24-h urinary DHPPA:creatinine ratio

    Time frame: Endpoint (Day 3)

  8. Total AR (DHBA+DHPPA):creatinine ratio in morning spot urine sample

    Time frame: Endpoint (Day 3)

  9. DHBA:creatinine ratio in morning spot urine sample

    Time frame: Endpoint (Day 3)

  10. DHPPA:creatinine ratio in morning spot urine sample

    Time frame: Endpoint (Day 3)

Other outcomes

  1. Estimated daily intake of WG wheat and rye cereals

    Time frame: Assessed throughout each intervention period (Days 1-3)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Registry information

Official study title

Urinary Alkylresorcinol Metabolites as a Biomarker of Whole Grain Wheat and Rye Intake

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 4, 2014
Registry last updated
Mar 6, 2015

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.

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