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Response of Alkylresorcinols to Different Cereals

This study is currently recruiting participants.
Verified August 2012 by Nestlé
Sponsor:
Information provided by (Responsible Party):
Alastair Ross, Nestle Research Center
ClinicalTrials.gov Identifier:
NCT01287403
First received: January 30, 2011
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  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: Control flour 1
Other: Control flour 2
Other: Test flour 1
Other: Test flour 2
Other: Test flour 3
Other: Test flour 4

Study Type: Interventional
Study Design: Allocation: Randomized
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:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Plasma alkylresorcinols [ Time Frame: From 0 to 48 h post dose. ] [ Designated as safety issue: No ]
    Plasma alkylresorcinols are biomarkers of wholegrain wheat, rye and barley intake. They will be measured using LC-MS/MS


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


Estimated Enrollment: 14
Study Start Date: January 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control flour 1
A negative control flour to serve as a reference.
 Other: Control flour 1
A treated cereal flour mixed with milk.
Active Comparator: Control flour 2
A control flour intervention with a known response.
 Other: Control flour 2
A treated cereal flour mixed with milk.
Experimental: Test flour 1
Flour with unknown response
 Other: Test flour 1
A treated cereal flour mixed with milk.
Experimental: Test flour 2
Test flour with unknown response.
 Other: Test flour 2
A treated cereal flour mixed with milk.
Experimental: Test flour 3
Test flour with unknown response.
 Other: Test flour 3
A treated cereal flour mixed with milk.
Experimental: Test flour 4
Test flour with unknown response.
 Other: Test flour 4
A treated cereal flour mixed with milk.

  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

Contacts
Contact: Maurice Beaumont, MD Maurice.Beaumont@rdls.nestle.com

Locations
Switzerland
Nestlé Research Center Recruiting
Lausanne, Vaude, Switzerland, 1000
Contact: Maurice Beaumont, MD         Maurice.Beaumont@rdls.nestle.com    
Principal Investigator: Alastair B Ross, PhD            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Alastair B Ross, PhD Nestlé
  More Information

No publications provided

Responsible Party: Alastair Ross, Dr, Nestle Research Center
ClinicalTrials.gov Identifier: NCT01287403     History of Changes
Other Study ID Numbers: 10.14 MET
Study First Received: January 30, 2011
Last Updated: August 9, 2012
Health Authority: Switzerland: Ethikkommission

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

ClinicalTrials.gov processed this record on June 17, 2013