Glycemic Response Testing

Sponsor

PepsiCo Global R&D (Industry)

Overall Status

Completed

CT.gov ID

NCT02020798

Collaborator

Glycemic Index Laboratories, Inc (Industry)

Enrollment

Location

Arms

Duration (Months)

18.7

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Study Start Date :

Dec 1, 2013

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 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

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

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

Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin [0-2 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1		Toronto		Canada

Sponsors and Collaborators

PepsiCo Global R&D
Glycemic Index Laboratories, Inc

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

PepsiCo Global R&D

ClinicalTrials.gov Identifier:

NCT02020798

Other Study ID Numbers:

PEP-1328

First Posted:

Dec 25, 2013

Last Update Posted:

Oct 30, 2014

Last Verified:

Oct 1, 2014

Study Results

No Results Posted as of Oct 30, 2014