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Glycaemic Responses to Cracker Snacks

This study has been completed.
Sponsor:
Collaborator:
Reading Scientific Services Ltd.
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01687569
First received: September 14, 2012
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.


Condition Intervention
Glycaemic Response Measurements
 Other: Control Cracker Snack
Other: Experimental Cracker Snack 1
Other: Experimental Cracker Snack 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack

Further study details as provided by Mondelēz International, Inc.:

Primary Outcome Measures:
  • Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC) [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]
    The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements. Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.


Enrollment: 27
Study Start Date: September 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Cracker
Base cracker snack
 Other: Control Cracker Snack
Base cracker snack
Experimental: Experimental Cracker Snack 1
Cracker snack containing test ingredient 1
 Other: Experimental Cracker Snack 1
Cracker snack containing test ingredient 1
Experimental: Experimental Cracker Snack 2
Cracker snack containing test ingredient 2
 Other: Experimental Cracker Snack 2
Cracker snack containing test ingredient 2

  Eligibility

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

Inclusion Criteria:

  • Male or female (not less than 40% Male)
  • Aged 18 - 55 years
  • Non Smokers
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Healthy, non-diabetic, no gastric bypass surgery
  • Not allergic to wheat, mustard, dairy, or soy
  • Have a fasting plasma glucose (finger-stick) <100 mg/dl (<5.5 mmol/L)
  • Willing and able to provide written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687569

Locations
United Kingdom
Reading Scientific Services Limited (RSSL)
Reading,, United Kingdom
Sponsors and Collaborators
Mondelēz International, Inc.
Reading Scientific Services Ltd.
Investigators
Principal Investigator: Rungano Munyuki Reading Scientific Services Limited
  More Information

No publications provided

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01687569     History of Changes
Other Study ID Numbers: P12-05774
Study First Received: September 14, 2012
Last Updated: May 7, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Mondelēz International, Inc.:
Glycaemic Response

ClinicalTrials.gov processed this record on May 22, 2013