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Response of Alkylresorcinols to Different Cereals

Not Applicable
Completed
Conditions
Healthy
Interventions
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
Registration Number
NCT01287403
Lead Sponsor
Société des Produits Nestlé (SPN)
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
14
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Refined wheat flourWholegrain barley flourA negative control flour to serve as a reference.
Liquid wholegrain barley flourRefined wheat flourTest flour with unknown response.
Liquid wholegrain barley flourWholegrain wheat flourTest flour with unknown response.
Esterase wholegrain wheat flourWholegrain barley flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Wholegrain barley flourRefined wheat flourTest flour with unknown response.
Refined wheat flourEsterase wholegrain wheat flourA negative control flour to serve as a reference.
Refined wheat flourWholegrain wheat flourA negative control flour to serve as a reference.
Refined wheat flourLiquid whole grain wheat flourA negative control flour to serve as a reference.
Esterase wholegrain wheat flourWholegrain wheat flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Wholegrain wheat flourLiquid whole grain wheat flourFlour with unknown response
Liquid whole grain wheat flourEsterase wholegrain wheat flourTest flour with unknown response.
Wholegrain barley flourEsterase wholegrain wheat flourTest flour with unknown response.
Wholegrain barley flourWholegrain wheat flourTest flour with unknown response.
Liquid wholegrain barley flourEsterase wholegrain wheat flourTest flour with unknown response.
Refined wheat flourLiquid wholegrain barley flourA negative control flour to serve as a reference.
Esterase wholegrain wheat flourLiquid whole grain wheat flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Wholegrain wheat flourRefined wheat flourFlour with unknown response
Wholegrain wheat flourWholegrain barley flourFlour with unknown response
Wholegrain wheat flourLiquid wholegrain barley flourFlour with unknown response
Liquid whole grain wheat flourLiquid wholegrain barley flourTest flour with unknown response.
Liquid wholegrain barley flourLiquid whole grain wheat flourTest flour with unknown response.
Liquid wholegrain barley flourWholegrain barley flourTest flour with unknown response.
Esterase wholegrain wheat flourRefined wheat flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Esterase wholegrain wheat flourLiquid wholegrain barley flourWholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)
Wholegrain wheat flourEsterase wholegrain wheat flourFlour with unknown response
Liquid whole grain wheat flourRefined wheat flourTest flour with unknown response.
Liquid whole grain wheat flourWholegrain wheat flourTest flour with unknown response.
Liquid whole grain wheat flourWholegrain barley flourTest flour with unknown response.
Wholegrain barley flourLiquid whole grain wheat flourTest flour with unknown response.
Wholegrain barley flourLiquid wholegrain barley flourTest flour with unknown response.
Primary Outcome Measures
NameTimeMethod
Plasma Alkylresorcinol CompoundsFrom 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 Outcome Measures
NameTimeMethod
Plasma and Urinary BetaineFrom 0 to 48 hours post dose
Phenolic Acids0-48 h post dose

Phenolic acids in plasma and urine

Trial Locations

Locations (1)

NESTEC / Clinical Development Unit / Metabolic Unit

🇨🇭

Lausanne, Vaud, Switzerland

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