Biomarkers of Whole Grain Wheat and Rye Intake

Sponsor

King's College London (Other)

Overall Status

Completed

CT.gov ID

NCT02155062

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Other: Whole grain rye Other: Whole grain wheat Other: Refined cereal	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

May 1, 2014

Actual Primary Completion Date :

Sep 1, 2014

Actual Study Completion Date :

Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whole grain rye 3-4 portions per day of WG rye containing foods (approximately 20 WG per portion)	Other: Whole grain rye Other: Refined cereal
Experimental: Whole grain wheat 3-4 portions per day of WG wheat containing foods (approximately 20 WG per portion)	Other: Whole grain wheat Other: Refined cereal
Placebo Comparator: 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)	Other: Refined cereal

Arm

Intervention/Treatment

Experimental: Whole grain rye

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

Other: Whole grain rye

Other: Refined cereal

Experimental: Whole grain wheat

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

Other: Whole grain wheat

Other: Refined cereal

Placebo Comparator: 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)

Other: Refined cereal

Outcome Measures

Primary Outcome Measures

24-h urinary DHBA:DHPPA ratio [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 Outcome Measures

DHBA:DHPPA ratio in morning spot urine [Endpoint (Day 3)]
Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion [Endpoint (Day 3)]
Total 24-h urinary DHBA excretion [Endpoint (Day 3)]
Total 24-h urinary DHPPA excretion [Endpoint (Day 3)]
24-h urinary total AR (DHBA+DHPPA):creatinine ratio [Endpoint (Day 3)]
24-h urinary DHBA:creatinine ratio [Endpoint (Day 3)]
24-h urinary DHPPA:creatinine ratio [Endpoint (Day 3)]
Total AR (DHBA+DHPPA):creatinine ratio in morning spot urine sample [Endpoint (Day 3)]
DHBA:creatinine ratio in morning spot urine sample [Endpoint (Day 3)]
DHPPA:creatinine ratio in morning spot urine sample [Endpoint (Day 3)]

Other Outcome Measures

Estimated daily intake of WG wheat and rye cereals [Assessed throughout each intervention period (Days 1-3)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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