Healthy Volunteers
Conditions
Keywords
Nutritional biomarker, Dietary assessment, Whole grain, Wheat, Rye, Alkylresorcinol, Urine
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.
Interventions
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 24-h urinary DHPPA:creatinine ratio | Endpoint (Day 3) |
| 24-h urinary total AR (DHBA+DHPPA):creatinine ratio | Endpoint (Day 3) |
| DHBA:DHPPA ratio in morning spot urine | Endpoint (Day 3) |
| Total 24-h urinary AR metabolite (DHBA + DHPPA) excretion | Endpoint (Day 3) |
| 24-h urinary DHBA:creatinine ratio | Endpoint (Day 3) |
| Total 24-h urinary DHPPA excretion | 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) |
| Total 24-h urinary DHBA excretion | Endpoint (Day 3) |
Other
| Measure | Time frame |
|---|---|
| Estimated daily intake of WG wheat and rye cereals | Assessed throughout each intervention period (Days 1-3) |
Countries
United Kingdom
Outcome results
None listed