Response of Alkylresorcinols to Different Cereals

Study Overview
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Brief Summary
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Cereal grains contain a wide variety of different phytochemicals which may play different roles in physiology. Their response in plasma and urine after a meal is poorly defined for most cereals. This study will investigate the plasma response and urinary excretion of cereal compounds after eating 6 different types of cereal preparation, with a focus on alkylresorcinols.

Detailed Description
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This was a cross-over, randomized, double blind study with 6 arms (flours of different composition). Thirteen subjects completed the trial, where 100 g of each flour, mixed with 300 mL milk, was fed to all subjects.

Official Title
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Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Conditions
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Healthy

Intervention / Treatment
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* Other: Refined wheat flour
* Other: Esterase wholegrain wheat flour
* Other: Wholegrain wheat flour
* Other: Liquid whole grain wheat flour
* Other: Wholegrain barley flour
* Other: Liquid wholegrain barley flour


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Normal-overweight (BMI 19-28 kg/m2) Non-smokers Exclusion Criteria: Regular consumers of wholegrain cereals Allergy to cereal or milk products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Refined wheat flour<br>A negative control flour to serve as a reference. | Other: Esterase wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid whole grain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|
| Active Comparator: Esterase wholegrain wheat flour<br>Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids) | Other: Refined wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid whole grain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|
| Experimental: Wholegrain wheat flour<br>Flour with unknown response | Other: Refined wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Esterase wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid whole grain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|
| Experimental: Liquid whole grain wheat flour<br>Test flour with unknown response. | Other: Refined wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Esterase wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|
| Experimental: Wholegrain barley flour<br>Test flour with unknown response. | Other: Refined wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Esterase wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid whole grain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|
| Experimental: Liquid wholegrain barley flour<br>Test flour with unknown response. | Other: Refined wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Esterase wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Liquid whole grain wheat flour<br>* A treated cereal flour mixed with milk.<br>Other: Wholegrain barley flour<br>* A treated cereal flour mixed with milk.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Alkylresorcinol Compounds | Area under the curve (AUC) over baseline of alkylresorcinol compounds are measured for the 6 interventional arms. Time points are: t = 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, 24 and 48 h after product intake. | From 0 to 48 h post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma and Urinary Betaine |  | From 0 to 48 hours post dose | 
| Phenolic Acids | Phenolic acids in plasma and urine | 0-48 h post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cereals, Alkylresorcinols, Betaine, Phenolics, Plasma and urine cereal phytochemicals