Response of Alkylresorcinols to Different Cereals

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CDUadmin, Nestlé
ClinicalTrials.gov Identifier:
NCT01287403
First received: January 30, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Healthy
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Resource links provided by NLM:


Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Plasma Alkylresorcinol Compounds [ Time Frame: From 0 to 48 h post dose. ] [ Designated as safety issue: No ]
    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:
  • Plasma and Urinary Betaine [ Time Frame: From 0 to 48 hours post dose ] [ Designated as safety issue: No ]
  • Phenolic Acids [ Time Frame: 0-48 h post dose ] [ Designated as safety issue: No ]
    Phenolic acids in plasma and urine


Enrollment: 14
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: Refined 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.
Experimental: Wholegrain wheat flour
Flour with unknown response
Other: Refined wheat flour
A treated cereal flour mixed with milk.
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.
Experimental: Liquid whole grain wheat flour
Test flour with unknown response.
Other: Refined wheat flour
A treated cereal flour mixed with milk.
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.
Experimental: Wholegrain barley flour
Test flour with unknown response.
Other: Refined wheat flour
A treated cereal flour mixed with milk.
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.
Experimental: Liquid wholegrain barley flour
Test flour with unknown response.
Other: Refined wheat flour
A treated cereal flour mixed with milk.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01287403

Locations
Switzerland
NESTEC / Clinical Development Unit / Metabolic Unit
Lausanne, Vaud, Switzerland, 1000
Sponsors and Collaborators
Nestlé
Investigators
Study Director: Alastair B Ross, PhD Nestlé
  More Information

No publications provided

Responsible Party: CDUadmin, Dr Beaumont, Nestlé
ClinicalTrials.gov Identifier: NCT01287403     History of Changes
Other Study ID Numbers: 10.14 MET
Study First Received: January 30, 2011
Results First Received: April 9, 2013
Last Updated: July 11, 2013
Health Authority: Switzerland: Swissmedic

Keywords provided by Nestlé:
Cereals
Alkylresorcinols
Betaine
Phenolics
Plasma and urine cereal phytochemicals

ClinicalTrials.gov processed this record on April 16, 2014