Response of Alkylresorcinols to Different Cereals

Response of Alkylresorcinols and Other Biomarkers 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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Esterase wholegrain wheat flour; Other: Wholegrain wheat flour; Other: Liquid whole grain wheat flour; Other: Wholegrain barley flour; Other: Liquid wholegrain barley flour; Other: Refined wheat flour

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1000
      • NESTEC / Clinical Development Unit / Metabolic Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Refined wheat flour; A negative control flour to serve as a reference.	Other: Esterase wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid whole grain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Liquid wholegrain barley flour; A treated cereal flour mixed with milk.
ACTIVE_COMPARATOR: Esterase wholegrain wheat flour; Wholegrain wheat flour treated with esterases to release phenolics (positive control for phenolic acids)	Other: Wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid whole grain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Liquid wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Refined wheat flour; A treated cereal flour mixed with milk.
EXPERIMENTAL: Wholegrain wheat flour; Flour with unknown response	Other: Esterase wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid whole grain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Liquid wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Refined wheat flour; A treated cereal flour mixed with milk.
EXPERIMENTAL: Liquid whole grain wheat flour; Test flour with unknown response.	Other: Esterase wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Liquid wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Refined wheat flour; A treated cereal flour mixed with milk.
EXPERIMENTAL: Wholegrain barley flour; Test flour with unknown response.	Other: Esterase wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid whole grain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Refined wheat flour; A treated cereal flour mixed with milk.
EXPERIMENTAL: Liquid wholegrain barley flour; Test flour with unknown response.	Other: Esterase wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain wheat flour; A treated cereal flour mixed with milk.; Other: Liquid whole grain wheat flour; A treated cereal flour mixed with milk.; Other: Wholegrain barley flour; A treated cereal flour mixed with milk.; Other: Refined wheat flour; A treated cereal flour mixed with milk.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Study Director: Alastair B Ross, PhD, Nestlé

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: January 30, 2011
• First Submitted That Met QC Criteria: January 31, 2011
• First Posted (ESTIMATE): February 1, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Alkylresorcinols; Betaine; Cereals; Phenolics; Plasma and urine cereal phytochemicals
• Other Study ID Numbers: 10.14 MET