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Glycemic Response Testing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02020798
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : October 30, 2014
Sponsor:
Collaborator:
Glycemic Index Laboratories, Inc
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief Summary:
The purpose of this study is to assess whether food ingredient(s) affect glycemic responses.

Condition or disease Intervention/treatment Phase
Glycemic Response Other: Dietary Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Study Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Arm Intervention/treatment
Placebo Comparator: Nutrient formulations without active ingredient
4 nutrient formulations without active ingredient and variable level of available placebo ingredient
Experimental: Nutrient formulation with active ingredien
4 nutrient formulations with increasing amount of active ingredient
Other: Dietary Intervention



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin [ Time Frame: 0-2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020798


Locations
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Canada
Toronto, Canada
Sponsors and Collaborators
PepsiCo Global R&D
Glycemic Index Laboratories, Inc
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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT02020798    
Other Study ID Numbers: PEP-1328
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: October 2014