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Glycemic Response Testing

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ClinicalTrials.gov Identifier: NCT01536860
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Collaborator:
Reading Scientific Services Ltd.
Information provided by (Responsible Party):
Mondelēz International, Inc.

Study Description
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Brief Summary:
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).

Condition or disease Intervention/treatment Phase
Glycemic Index Glycemic Response Other: Dietary Intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Glycaemic Response Testing
Study Start Date : February 2012
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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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
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United Kingdom
Reading Scientific Services Limited (RSSL)
Reading, Berkshire, United Kingdom, RG6 6BZ
Sponsors and Collaborators
Mondelēz International, Inc.
Reading Scientific Services Ltd.
Investigators
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Principal Investigator: Valerie Hart, SCS, Dip, MICR RSSL
More Information
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Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01536860    
Other Study ID Numbers: P12-00794
First Posted: February 22, 2012    Key Record Dates
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: November 2013