Clinical trial NCT02155062: Biomarkers of Whole Grain Wheat and Rye Intake
Official title: Urinary Alkylresorcinol Metabolites as a Biomarker of Whole Grain Wheat and Rye Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Nutritional biomarker
Dietary assessment
Whole grain
Wheat
Rye
Alkylresorcinol
Urine
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 24-h urinary DHBA:DHPPA ratio
timeFrame: Endpoint (Day 3)
Secondary outcomes:
measure: DHBA:DHPPA ratio in morning spot urine
timeFrame: Endpoint (Day 3)
measure: Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion
timeFrame: Endpoint (Day 3)
measure: Total 24-h urinary DHBA excretion
timeFrame: Endpoint (Day 3)
measure: Total 24-h urinary DHPPA excretion
timeFrame: Endpoint (Day 3)
measure: 24-h urinary total AR (DHBA+DHPPA):creatinine ratio
timeFrame: Endpoint (Day 3)
measure: 24-h urinary DHBA:creatinine ratio
timeFrame: Endpoint (Day 3)
measure: 24-h urinary DHPPA:creatinine ratio
timeFrame: Endpoint (Day 3)
measure: Total AR (DHBA+DHPPA):creatinine ratio in morning spot urine sample
timeFrame: Endpoint (Day 3)
measure: DHBA:creatinine ratio in morning spot urine sample
timeFrame: Endpoint (Day 3)
measure: DHPPA:creatinine ratio in morning spot urine sample
timeFrame: Endpoint (Day 3)
Other outcomes:
measure: Estimated daily intake of WG wheat and rye cereals
timeFrame: Assessed throughout each intervention period (Days 1-3)
Locations:
city: London
country: United Kingdom
facility: Diabetes and Nutritional Sciences Division, King's College London
Study officials:
affiliation: King's College London
name: Julia Darzi, PhD
role: PRINCIPAL_INVESTIGATOR
References: