Unknown statusInterventionalNot ApplicableUpdated Oct 30, 2014
PEP-1324: Glycemic Response Testing
ClinicalTrials.gov ID
NCT02037854
Lead Sponsor
PepsiCo Global R&DINDUSTRY
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
12Estimated
Last Update Posted
Oct 30, 2014Estimated
Start Date
Jan 2014
Primary Completion Date
Jun 2014Actual
Brief Summary
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.
Glycemic Response
Nutrient formulation
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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.