- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01536847
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
|
300 ml of liquid food product
300 mL of liquid food product
|
EXPERIMENTAL: Experimental Test Drink 1
Control drink containing ingredient 1
|
300 ml of liquid food product
300 mL of liquid food product
|
EXPERIMENTAL: Experimental Test Drink 2
Control drink containing ingredient 2
|
300 ml of liquid food product
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
Collaborators
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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