NCT02155062

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

May 29, 2014

Last Update Submit

March 5, 2015

Conditions

Healthy Volunteers

Keywords

Nutritional biomarkerDietary assessmentWhole grainWheatRyeAlkylresorcinolUrine

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (10)

  • 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)

  • +5 more secondary outcomes

Other Outcomes (1)

  • Estimated daily intake of WG wheat and rye cereals

    Assessed throughout each intervention period (Days 1-3)

Study Arms (3)

Whole grain rye

EXPERIMENTAL

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

Other: Whole grain ryeOther: Refined cereal

Whole grain wheat

EXPERIMENTAL

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

Other: Whole grain wheatOther: Refined cereal

Refined cereal

PLACEBO COMPARATOR

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

Interventions

Whole grain ryeOTHER
Whole grain rye
Whole grain wheatOTHER
Whole grain wheat
Refined cerealOTHER
Refined cerealWhole grain ryeWhole grain wheat

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass intake 18.5-30.0 kg/m2
  • Weight stable for 2 months
  • Generally healthy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes and Nutritional Sciences Division, King's College London

London, SW1 9NH, United Kingdom

Location

Study Officials

  • Julia Darzi, PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Nutrition and Dietetics

Study Record Dates

First Submitted

May 29, 2014

First Posted

June 4, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

GB(1)