Glycemic Response Testing

• ClinicalTrials.gov Identifier: NCT02020798
• Recruitment Status: Completed
• First Posted: December 25, 2013
• Last Update Posted: October 30, 2014
• Sponsor: PepsiCo Global R&D
• Collaborator: Glycemic Index Laboratories, Inc
• Information provided by (Responsible Party): PepsiCo Global R&D

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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:

-

Contacts and Locations

Locations

Canada

Toronto, Canada

Sponsors and Collaborators

PepsiCo Global R&D

Glycemic Index Laboratories, Inc

More Information

• Responsible Party: PepsiCo Global R&D
• ClinicalTrials.gov Identifier: NCT02020798
• Other Study ID Numbers: PEP-1328
• First Posted: December 25, 2013
• Last Update Posted: October 30, 2014
• Last Verified: October 2014