Glycemic and Insulinemic Impact of a Test Granola 3 Versus a Control Granola (NCT03491514) | Clinical Trial Compass
CompletedNot Applicable
Glycemic and Insulinemic Impact of a Test Granola 3 Versus a Control Granola
Canada40 participantsStarted 2018-01-17
Plain-language summary
The objectives of this study are to examine the blood glucose and serum insulin response elicited by servings of Test Granola and Control Granola containing equal amounts of available carbohydrate over a 3 h time period. In addition, the subjective hunger response to these foods will be measured over 3 h.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Male or non-pregnant, non-lactating females, 18-65 years of age, inclusive
* Body mass index (BMI) between 21.0 and 32.0 kg/m², inclusive, at screening (visit 1).
* No participation in a PepsiCo study at GI Labs for at least 6 months from signing the consent form or previously enrolled into a PepsiCo Granola RAG:SAG trial (PEP-1701, PEP-1710).
* No participation in any clinical trial for at least 30 days from signing the consent form.
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
* Willing to maintain current dietary supplement use throughout the trial. On test days, subject agrees not to take any dietary supplements until dismissal from the GI labs. Failure to comply will result in a rescheduled test visit.
* Fasting serum glucose \<7.0mmol/L or capillary whole blood glucose \<6.3mmol/L.
* Willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
* Absence of health conditions that would prevent fulfillment of study requirements as judged by the Investigator on the basis of medical history.
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.
Exclusion Criteria:
* Failure to meet any one of the inclusion criteria
* Known history of AIDS, h…