Biomarkers of Whole Grain Wheat and Rye Intake

King's College London

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Refined cereal; Other: Whole grain rye; Other: Whole grain wheat

Study type: Interventional

Funder types: Other

Identifiers

NCT02155062

BDM/13/14-78

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 3 patient groups, including a placebo group

Whole grain rye

Experimental group

Description:

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

Treatment:

Other: Whole grain rye

Other: Refined cereal

Whole grain wheat

Experimental group

Description:

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

Treatment:

Other: Whole grain wheat

Other: Refined cereal

Refined cereal

Placebo Comparator group

Description:

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

Treatment:

Other: Refined cereal