Biomarkers of Whole Grain Wheat and Rye Intake

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02155062
• Other study ID #: BDM/13/14-78
• Status: Completed
• Phase: N/A
• First received: May 29, 2014
• Last updated: March 5, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Whole grain rye

• Whole grain wheat

• Refined cereal

Locations

Country	Name	City	State
United Kingdom	Diabetes and Nutritional Sciences Division, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated daily intake of WG wheat and rye cereals		Assessed throughout each intervention period (Days 1-3)	No
Primary	24-h urinary DHBA:DHPPA ratio	DHBA: 3,5-dihydroxybenzoic acid DHPPA: 3-(3,5-dihydroxyphenyl)-propanoic acid; DHBA & DHPPA are the main AR metabolites excreted in urine	Endpoint (Day 3)	No
Secondary	DHBA:DHPPA ratio in morning spot urine		Endpoint (Day 3)	No
Secondary	Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion		Endpoint (Day 3)	No
Secondary	Total 24-h urinary DHBA excretion		Endpoint (Day 3)	No
Secondary	Total 24-h urinary DHPPA excretion		Endpoint (Day 3)	No
Secondary	24-h urinary total AR (DHBA+DHPPA):creatinine ratio		Endpoint (Day 3)	No
Secondary	24-h urinary DHBA:creatinine ratio		Endpoint (Day 3)	No
Secondary	24-h urinary DHPPA:creatinine ratio		Endpoint (Day 3)	No
Secondary	Total AR (DHBA+DHPPA):creatinine ratio in morning spot urine sample		Endpoint (Day 3)	No
Secondary	DHBA:creatinine ratio in morning spot urine sample		Endpoint (Day 3)	No
Secondary	DHPPA:creatinine ratio in morning spot urine sample		Endpoint (Day 3)	No