NCT01287403CompletedNot Applicable

Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Société des Produits Nestlé (SPN)1 site in 1 country14 target enrollmentStarted: January 1, 2011Last updated: August 31, 2018

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor
Enrollment: 14
Locations: 1
Primary Endpoint: Plasma Alkylresorcinol Compounds

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Basic Science
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 55 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Normal-overweight (BMI 19-28 kg/m2)
•Non-smokers

Exclusion Criteria

•Regular consumers of wholegrain cereals
•Allergy to cereal or milk products

Arms & Interventions

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

Intervention: Liquid wholegrain barley flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Liquid whole grain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

Intervention: Esterase wholegrain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

Intervention: Wholegrain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

Intervention: Liquid whole grain wheat flour (Other)

Refined wheat flour

Placebo Comparator

A negative control flour to serve as a reference.

Intervention: Wholegrain barley flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

Intervention: Refined wheat flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

Intervention: Wholegrain wheat flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

Intervention: Liquid whole grain wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Refined wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Esterase wholegrain wheat flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

Intervention: Wholegrain barley flour (Other)

Esterase wholegrain wheat flour

Active Comparator

Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)

Intervention: Liquid wholegrain barley flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

Intervention: Refined wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

Intervention: Esterase wholegrain wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

Intervention: Liquid whole grain wheat flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Wholegrain wheat flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

Intervention: Wholegrain barley flour (Other)

Wholegrain wheat flour

Experimental

Flour with unknown response

Intervention: Liquid wholegrain barley flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

Intervention: Refined wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

Intervention: Esterase wholegrain wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

Intervention: Wholegrain wheat flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

Intervention: Wholegrain barley flour (Other)

Liquid whole grain wheat flour

Experimental

Test flour with unknown response.

Intervention: Liquid wholegrain barley flour (Other)

Wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Liquid wholegrain barley flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Refined wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Esterase wholegrain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Wholegrain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Liquid whole grain wheat flour (Other)

Liquid wholegrain barley flour

Experimental

Test flour with unknown response.

Intervention: Wholegrain barley flour (Other)

Outcomes

Primary Outcomes

Plasma Alkylresorcinol Compounds

Time Frame: From 0 to 48 h post dose.

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.

Secondary Outcomes

Plasma and Urinary Betaine(From 0 to 48 hours post dose)
Phenolic Acids(0-48 h post dose)

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Sponsor Class

Industry

Responsible Party

Principal Investigator

CDUuser

MD, PhD

Société des Produits Nestlé (SPN)

Study Sites (1)

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