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
  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 Blind (Subject, 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 ] [ 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.


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

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% 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
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: 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

No publications provided

Responsible Party: Mondelēz International, Inc.
ClinicalTrials.gov Identifier: NCT01536860     History of Changes
Other Study ID Numbers: P12-00794
Study First Received: February 16, 2012
Results First Received: September 11, 2012
Last Updated: November 5, 2013
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on August 28, 2014