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OpenTrials
Completed

NCT Number: NCT01287403

Response of Alkylresorcinols to Different Cereals

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NESTEC / Clinical Development Unit / Metabolic Unit

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Refined wheat flour

Other

A treated cereal flour mixed with milk.

Esterase wholegrain wheat flour

Other

A treated cereal flour mixed with milk.

Wholegrain wheat flour

Other

A treated cereal flour mixed with milk.

Liquid whole grain wheat flour

Other

A treated cereal flour mixed with milk.

Wholegrain barley flour

Other

A treated cereal flour mixed with milk.

Liquid wholegrain barley flour

Other

A treated cereal flour mixed with milk.

Primary outcomes

  1. 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

  1. Plasma and Urinary Betaine

    Time frame: From 0 to 48 hours post dose

  2. Phenolic Acids

    Time frame: 0-48 h post dose

    Phenolic acids in plasma and urine

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2011
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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