Glycemic Response Testing

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

Study Overview

• Status: Completed
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Dietary Intervention

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Toronto, Canada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental area under the blood glucose response curve	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.	0-2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin	0-2 hours

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Collaborators: Glycemic Index Laboratories, Inc

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): February 1, 2014
• Study Completion (ACTUAL): February 1, 2014

Study Registration Dates

• First Submitted: December 19, 2013
• First Submitted That Met QC Criteria: December 19, 2013
• First Posted (ESTIMATE): December 25, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 30, 2014
• Last Update Submitted That Met QC Criteria: October 29, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1328