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PEP-1324: Glycemic Response Testing

Sponsor
PepsiCo Global R&D (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02037854
Collaborator
(none)
12
Enrollment
1
Location
2
Arms

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Nutrient formulation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

A nutrient formulation without the active ingredient

Other: Nutrient formulation
Experimental: Nutrient formulation

Nutrient formulations with variable amounts of active ingredients.

Other: Nutrient formulation

Outcome Measures

Primary Outcome Measures

  1. Incremental area under the blood glucose response cruve [0-2 hours]

Secondary Outcome Measures

  1. peak blood glucose [0-2 hours]

  2. peak 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 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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 GI Labs Toronto Ontario Canada M5C 2N8

Sponsors and Collaborators

  • PepsiCo Global R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PepsiCo Global R&D
ClinicalTrials.gov Identifier:
NCT02037854
Other Study ID Numbers:
  • PEP-1324
First Posted:
Jan 16, 2014
Last Update Posted:
Oct 30, 2014
Last Verified:
Oct 1, 2014

Study Results

No Results Posted as of Oct 30, 2014