Glycemic Response Testing
Glycaemic Response Testing
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
November 27, 2013
CompletedNovember 27, 2013
November 1, 2013
29 days
February 16, 2012
September 11, 2012
November 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Control Test Drink
PLACEBO COMPARATORcontrol drink
Experimental Test Drink 1
EXPERIMENTALcontrol drink containing ingredient 1
Experimental Test Drink 2
EXPERIMENTALControl drink containing ingredient 2
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mondelēz International, Inc.lead
- Reading Scientific Services Ltd.collaborator
Study Sites (1)
Reading Scientific Services Limited (RSSL)
Reading, Berkshire, RG6 6BZ, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rungano Munyuki
- Organization
- RSSL
Study Officials
- PRINCIPAL INVESTIGATOR
Valerie Hart, SCS, Dip, MICR
RSSL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
February 1, 2012
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 27, 2013
Results First Posted
November 27, 2013
Record last verified: 2013-11