Biomarkers of Whole Grain Wheat and Rye Intake

NCT ID: NCT02155062

Last Updated: 2015-03-06

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Whole grain rye

3-4 portions per day of WG rye containing foods (approximately 20 WG per portion)

Group Type EXPERIMENTAL

Whole grain rye

Intervention Type OTHER

Refined cereal

Intervention Type OTHER

Whole grain wheat

3-4 portions per day of WG wheat containing foods (approximately 20 WG per portion)

Group Type EXPERIMENTAL

Whole grain wheat

Intervention Type OTHER

Refined cereal

Intervention Type OTHER

Refined cereal

No intake of WG wheat or WG rye cereals, only refined cereals or non-AR containing WG cereals (e.g. WG rice or oats)

Group Type PLACEBO_COMPARATOR

Refined cereal

Intervention Type OTHER

Interventions

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Whole grain rye

Intervention Type OTHER

Whole grain wheat

Intervention Type OTHER

Refined cereal

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King's College London

OTHER

Sponsor Role lead

Responsible Party

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Dr Julia Darzi

Lecturer Nutrition and Dietetics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julia Darzi, PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Diabetes and Nutritional Sciences Division, King's College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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BDM/13/14-78

Identifier Type: -

Identifier Source: org_study_id

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