Glycemic Response Testing

NCT02020798 | Completed

• 1 other identifier: PEP-1328
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glycemic Response

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Rate of decline in blood glucose, peak blood glucose, peak insulin and adjusted time concentration area for insulin

  0-2 hours

Study Arms (2)

Nutrient formulations without active ingredient

PLACEBO COMPARATOR

4 nutrient formulations without active ingredient and variable level of available placebo ingredient

Nutrient formulation with active ingredien

EXPERIMENTAL

4 nutrient formulations with increasing amount of active ingredient

Other: Dietary Intervention

Interventions

Dietary Intervention OTHER

Nutrient formulation with active ingredien

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead
• Glycemic Index Laboratories, Inc: collaborator

Study Sites (1)

Unknown Facility

Toronto, Canada

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2013
• First Posted: December 25, 2013
• Study Start: December 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: October 30, 2014

Record last verified: 2014-10

Locations

CA (1)