Glucose and Insulin Responses to Test Foods

NCT01671878 — Not applicable, Completed, 12 participants, Mondelēz International, Inc.

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Characterization of the Postprandial Glucose and Insulin Responses to Test Foods in Lean and Overweight Subjects

RegistryNCT01671878
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, crossover, masking: none
Enrollment12 (Actual)
SponsorMondelēz International, Inc. (Industry); collaborators: Glycemic Index Laboratories, Inc
ConditionsGlucose Response, Insulin Response
InterventionsReference Glucose, Test Food 1 (Cereal), Test Food 2 (Biscuit) (Other)
Datesstart 2012-09-01, primary completion 2012-11-01, completion 2012-11-01, first posted 2012-08-24, last updated 2013-05-07
Locations1 site in Canada

Related Papers Related Patents Related Grants Related Experts
All trials for Glucose Response All trials for Insulin Response All trials of Reference Glucose All trials of Test Food 1 (Cereal)

-Summary

In this study, postprandial glucose and insulin responses of different foods will be measured in individuals with varying body weight.

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+Arms and interventions

ArmTypeInterventionsDescription
Reference GlucoseOtherOther: Reference GlucoseGlucose standard
Test Food 1ExperimentalOther: Test Food 1 (Cereal)Cereal
Test Food 2ExperimentalOther: Test Food 2 (Biscuit)Biscuit
  • Reference Glucose (Other)
  • Test Food 1 (Cereal) (Other)
  • Test Food 2 (Biscuit) (Other)

+Outcome measures

Primary outcomes

  • Postprandial Glucose Response [3 hours]

Secondary outcomes

  • Postprandial Insulin Response [3 hours]

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Participants will be non-smoking males or non-pregnant females aged 20-45y, with normal glycemia and in good health. A total of 12 participants will be included, where approximately half will be male \& half female, and half normal weight (BMI > 19.0 and < 25.0) and half overweight but not obese (BMI > 25.0 and < 30). Thus, no fewer than 5 male, 5 female, 5 normal weight and 5 overweight but not obese subjects will be included. Additional inclusion criteria will include:
* 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

Exclusion Criteria:

* failure to meet any one of the inclusion criteria
* 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
* General anaesthesia in the month prior to inclusion.
* Smokers

+Locations (1)

FacilityCityCountryStatus
Glycemic Index LaboratoriesToronto, OntarioCanada

+Investigators