Glycaemic Response Testing

September 7, 2012 updated by: Mondelēz International, Inc.
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • Having a fasting plasma glucose (finger stick) <100 mg/dl (<5.5 mmol/L)
  • Willing and able to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Control Test Drink
Control drink
Other: Dietary Intervention
300 ml of liquid food product
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
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
Other: Dietary Intervention
300 mL of liquid food product

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycaemic index of experimental test food using capillary blood
Time Frame: 0-120 minutes
0-120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mondelēz International, Inc.

Collaborators

Reading Scientific Services Ltd.

Investigators

  • Principal Investigator: Suzana Louth, Dr, RSSL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

January 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)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • P11-09257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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