Toronto, Canada
NCT Number: NCT02020798
Glycemic Response Testing
The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Subject is 18-75 years of age
- Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
- Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
- Subject has no health conditions that would prevent him from fulfilling the study requirements as judged by the Investigator on the basis of medical history.
- Subject understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
Exclusion criteria
-
Treatment and study plan
Dietary Intervention
OtherPrimary outcomes
-
Incremental area under the blood glucose response curve
Time frame: 0-2 hours
Glycemic response calculated from individual glucose measurements upon consumption of control and experimental test food products. The individual glucose measurements will be collected at baseline (prior to consumption of each test food product) and over a 2-hour period following the initiation of consumption of each test food product. The primary outcome is differential treatment-effect on the time-concentration glucose curve over the 2 hours post consumption of each test food product.
Secondary outcomes
-
Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin
Time frame: 0-2 hours
Sponsors and collaborators
Lead sponsor
PepsiCo Global R&D
Industry
Collaborators
- Glycemic Index Laboratories, Inc
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2014
- Study completion
- 2014
- First posted
- Dec 25, 2013
- Registry last updated
- Oct 30, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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