- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687569
Glycaemic Responses to Cracker Snacks
May 7, 2013 updated by: Mondelēz International, Inc.
Effects of Added Spice Flour on Glycaemic Responses to a Cracker Snack
The purpose of this study is to determine whether added ingredient affects glycaemic responses to a cracker snack.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Reading,, United Kingdom
- Reading Scientific Services Limited (RSSL)
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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% Male)
- Aged 18 - 55 years
- Non Smokers
- Have a body mass index between 18.5 to 29.99 kg/m2
- Healthy, non-diabetic, no gastric bypass surgery
- Not allergic to wheat, mustard, dairy, or soy
- Have 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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control Cracker
Base cracker snack
|
Base cracker snack
|
Experimental: Experimental Cracker Snack 1
Cracker snack containing test ingredient 1
|
Cracker snack containing test ingredient 1
|
Experimental: Experimental Cracker Snack 2
Cracker snack containing test ingredient 2
|
Cracker snack containing test ingredient 2
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glycaemic Response(s) to cracker snacks as measured by incremental Area Under the Curve (iAUC)
Time Frame: 120 minutes
|
The endpoint will be the blood glucose response curve, calculated from the individual glucose measurements.
Evaluated by repeated measures ANOVA on incremental AUC measured in capillary blood.
|
120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rungano Munyuki, Reading Scientific Services Limited
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
September 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
September 14, 2012
First Submitted That Met QC Criteria
September 14, 2012
First Posted (Estimate)
September 19, 2012
Study Record Updates
Last Update Posted (Estimate)
May 9, 2013
Last Update Submitted That Met QC Criteria
May 7, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P12-05774
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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