Glycemic Response Testing

This study has been completed.
Sponsor:
Collaborator:
Reading Scientific Services Ltd.
Information provided by (Responsible Party):
Mondelēz International, Inc.
ClinicalTrials.gov Identifier:
NCT01536860
First received: February 16, 2012
Last updated: November 5, 2013
Last verified: November 2013

February 16, 2012
November 5, 2013
February 2012
March 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Glycemic response upon consumption of control and experimental test food products [ Time Frame: 0-120 minutes ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01536860 on ClinicalTrials.gov Archive Site
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Glycemic Response Testing
Glycaemic Response Testing

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Glycemic Index
  • Glycemic Response
Other: Dietary Intervention
300 ml of liquid food product
  • Placebo Comparator: Control Test Drink
    control drink
    Intervention: Other: Dietary Intervention
  • Experimental: Experimental Test Drink 1
    control drink containing ingredient 1
    Intervention: Other: Dietary Intervention
  • Experimental: Experimental Test Drink 2
    Control drink containing ingredient 2
    Intervention: Other: Dietary Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01536860
P12-00794
No
Mondelēz International, Inc.
Mondelēz International, Inc.
Reading Scientific Services Ltd.
Principal Investigator: Valerie Hart, SCS, Dip, MICR RSSL
Mondelēz International, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP