Response of Alkylresorcinols to Different Cereals

NCT ID: NCT01287403

Last Updated: 2018-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Refined wheat flour

A negative control flour to serve as a reference.

Group Type PLACEBO_COMPARATOR

Esterase wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

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

Group Type ACTIVE_COMPARATOR

Refined wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Flour with unknown response

Group Type EXPERIMENTAL

Refined wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Test flour with unknown response.

Group Type EXPERIMENTAL

Refined wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Test flour with unknown response.

Group Type EXPERIMENTAL

Refined wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Test flour with unknown response.

Group Type EXPERIMENTAL

Refined wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Wholegrain barley flour

Intervention Type OTHER

A treated cereal flour mixed with milk.

Interventions

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Refined wheat flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

Esterase wholegrain wheat flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

Wholegrain wheat flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

Liquid whole grain wheat flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

Wholegrain barley flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

Liquid wholegrain barley flour

A treated cereal flour mixed with milk.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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CDUuser

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alastair B Ross, PhD

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Locations

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NESTEC / Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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10.14 MET

Identifier Type: -

Identifier Source: org_study_id

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