PEP-1324: Glycemic Response Testing

Not Applicable

• Conditions: Glycemic Response
• Interventions: Other: Nutrient formulation

• Registration Number: NCT02037854
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-16
• Primary Completion: 2014-06
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutrient formulation	Nutrient formulation	Nutrient formulations with variable amounts of active ingredients.
Placebo	Nutrient formulation	A nutrient formulation without the active ingredient

Primary Outcome Measures

Name	Time	Method
Incremental area under the blood glucose response cruve	0-2 hours

Secondary Outcome Measures

Name	Time	Method
peak insulin	0-2 hours
peak blood glucose	0-2 hours

Trial Locations

Locations (1)

GI Labs; 🇨🇦 Toronto, Ontario, Canada