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Glycemic Response Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01536860
First Posted: February 22, 2012
Last Update Posted: November 27, 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.
Collaborator:
Reading Scientific Services Ltd.
Information provided by (Responsible Party):
Mondelēz International, Inc.
  Purpose
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

Condition Intervention
Glycemic Index Glycemic Response Other: Dietary Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Glycaemic Response Testing

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

Primary Outcome Measures:
  • Glycemic Response Measured as the Positive Incremental Area Under the Time-concentration Curve(iAUC) Calculated From Individual Glucose Measurements Upon Consumption of Control and Experimental Test Food Products [ Time Frame: 0-120 minutes ]
    The individual glucose measurements were collected at baseline (prior to consumption of each test food product and 15, 30, 45, 60, 90 and 120 minutes following the initiation of consumption of each test food product. The positive incremental area under the time-concentration curve (iAUC) was then calculated for the entire 120 minutes after consumption of each test food product. The results show the differential treatment-related effect on the time-concentration curve (iAUC) for the entire 120 minutes post consumption of each test food product.


Enrollment: 12
Study Start Date: February 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Test Drink
control drink
Other: Dietary Intervention
300 ml of liquid food product
Experimental: Experimental Test Drink 1
control drink containing ingredient 1
Other: Dietary Intervention
300 ml of liquid food product
Experimental: Experimental Test Drink 2
Control drink containing ingredient 2
Other: Dietary Intervention
300 ml of liquid food product

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female (not less than 40% males or females
  • Non-smoker
  • Aged 18 to 55 years
  • Have a body mass index between 18.5 to 29.99 kg/m2
  • Healthy, non-diabetic, no gastric bypass surgery
  • Not allergic to mustard, dairy or soy
  • Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
  • Willing and able to provide written informed consent
  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): NCT01536860


Locations
United Kingdom
Reading Scientific Services Limited (RSSL)
Reading, Berkshire, United Kingdom, RG6 6BZ
Sponsors and Collaborators
Mondelēz International, Inc.
Reading Scientific Services Ltd.
Investigators
Principal Investigator: Valerie Hart, SCS, Dip, MICR RSSL
  More Information

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01536860     History of Changes
Other Study ID Numbers: P12-00794
First Submitted: February 16, 2012
First Posted: February 22, 2012
Results First Submitted: September 11, 2012
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: November 2013