PEP-1324: Glycemic Response Testing

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

Study Overview

• Status: Unknown
• Conditions: Glycemic Response
• Intervention / Treatment: Other: Nutrient formulation

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2N8
      • Recruiting
      • GI Labs
      • Contact: Janice Campbell; Email: JCampbell@gilabs.com

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 is male or non-pregnant females, 18-75 years of age, inclusive
• Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
• Subject has to be non-smoker.
• Subject is willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial.
• Subject is 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.
• Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
• Subject is willing to abstain from alcohol consumption and avoid vigorous physical activity for 24 h prior to all test visits.
• 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 Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; A nutrient formulation without the active ingredient	Other: Nutrient formulation
Experimental: Nutrient formulation; Nutrient formulations with variable amounts of active ingredients.	Other: Nutrient formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incremental area under the blood glucose response cruve	0-2 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
peak blood glucose	0-2 hours
peak insulin	0-2 hours

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 13, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 16, 2014

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-1324 (PepsiCo)