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Response of Alkylresorcinols to Different Cereals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01287403
First Posted: February 1, 2011
Last Update Posted: August 14, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CDUadmin, Nestlé
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Response of Alkylresorcinols and Other Biomarkers to Different Cereals

Further study details as provided by CDUadmin, Nestlé:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Plasma and Urinary Betaine [ Time Frame: From 0 to 48 hours post dose ]
  • Phenolic Acids [ Time Frame: 0-48 h post dose ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: CDUadmin, Dr Beaumont, Nestlé
ClinicalTrials.gov Identifier: NCT01287403     History of Changes
Other Study ID Numbers: 10.14 MET
First Submitted: January 30, 2011
First Posted: February 1, 2011
Results First Submitted: April 9, 2013
Results First Posted: August 14, 2013
Last Update Posted: August 14, 2013
Last Verified: July 2013

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