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
  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
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: 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 October 21, 2014