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).

Study Overview

• Status: Completed
• Conditions: Glycemic Index; Glycemic Response
• Intervention / Treatment: Other: Dietary Intervention

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Berkshire
    • Reading, Berkshire, United Kingdom, RG6 6BZ
      • Reading Scientific Services Limited (RSSL)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	0-120 minutes

Collaborators and Investigators

• Sponsor: Mondelēz International, Inc.
• Collaborators: Reading Scientific Services Ltd.
• Investigators: Principal Investigator: Valerie Hart, SCS, Dip, MICR, RSSL

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: February 16, 2012
• First Submitted That Met QC Criteria: February 16, 2012
• First Posted (Estimate): February 22, 2012

Study Record Updates

• Last Update Posted (Estimate): November 27, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: P12-00794