Glycemic Response Testing

Not Applicable

Completed

• Conditions: Glycemic Response
• Interventions: Other: Dietary Intervention

• Registration Number: NCT02020798
• Lead Sponsor: PepsiCo Global R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-19
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-29
• Last Update Posted: 2014-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nutrient formulation with active ingredien	Dietary Intervention	4 nutrient formulations with increasing amount of active ingredient

Primary Outcome Measures

Name	Time	Method
Incremental area under the blood glucose response curve	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

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