Glycemic Response Testing

Glycemic Response Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02020798
• Other study ID #: PEP-1328
• Status: Completed
• Phase: N/A
• First received: December 19, 2013
• Last updated: October 29, 2014
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2014
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Glycemic Response

Intervention

Other:
• Dietary Intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
PepsiCo Global R&D	Glycemic Index Laboratories, Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin		0-2 hours	No