Glucose and Insulin Responses to Test Foods
Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects
1 other identifier
interventional
12
1 country
1
Brief Summary
In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.
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 Sep 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
First Submitted
Initial submission to the registry
August 21, 2012
CompletedFirst Posted
Study publicly available on registry
August 24, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMay 7, 2013
May 1, 2013
2 months
August 21, 2012
May 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Postprandial Glucose Response
3 hours
Secondary Outcomes (1)
Postprandial Insulin Response
3 hours
Study Arms (3)
Reference Glucose
OTHERGlucose standard
Test Food 1
EXPERIMENTALCereal
Test Food 2
EXPERIMENTALBiscuit
Interventions
Eligibility Criteria
You may qualify if:
- Absence of diabetes, impaired glucose tolerance and impaired fasting glucose, defined as having a fasting plasma glucose \< 5.6 mmol/L (100 mg/dL) AND plasma glucose levels \< 7.8 mmol/L (140 mg/dL) 2h after consumption of a 50 g glucose drink (OGTT will be administered during the screening visit)
- Systolic blood pressure 100-150 mmHg inclusive
- Diastolic blood pressure 60-90 mmHg inclusive
- Resting heart rate 50-90 beats/min inclusive after 3 minute rest
- Able to refrain from eating legumes and drinking alcohol the day before each test session
- Fasting triglycerides \< 2.0 mmol/L (178 mg/dL)
- Fasting HDL cholesterol \> 0.9 mmol/L (35 mg/dL) for males and \> 1.1mmol/L (42 mg/dL) for females
- Fasting LDL cholesterol \< 5.0 mmol/L (193 mg/dL)
- AST and ALT \< 120% of upper limit of normal (ULN)
- hsCRP \< 10 mg/L
- Urea and creatinine \< 150% ULN
You may not qualify if:
- age less than 18 or over 45 years
- known history or AIDS, hepatitis, diabetes or a heart condition
- participants using medications or with any condition which might, in the opinion of Dr. Wolever, the president of GI Testing, either: 1) make participation dangerous to the subject or to others, or 2) affect the results
- participants who cannot or will not comply with the experimental procedures or do not follow GI Labs safety guidelines.
- Food allergies of any kind
- Smokers
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mondelēz International, Inc.lead
- Glycemic Index Laboratories, Inccollaborator
Study Sites (1)
Glycemic Index Laboratories
Toronto, Ontario, M5C 2N8, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Wolever, MD, PhD
Glycemic Index Laboratories, Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2012
First Posted
August 24, 2012
Study Start
September 1, 2012
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
May 7, 2013
Record last verified: 2013-05