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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 16, 2014