NCT02037854UnknownNot Applicable
PEP-1324: Glycemic Response Testing
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- PepsiCo Global R&D
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Incremental area under the blood glucose response cruve
Study Overview
Brief Summary
The purpose of this study is to assess whether food ingredient(s) affect glycemic and insulinemic responses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- Not provided
Arms & Interventions
Placebo
Placebo Comparator
A nutrient formulation without the active ingredient
Intervention: Nutrient formulation (Other)
Nutrient formulation
Experimental
Nutrient formulations with variable amounts of active ingredients.
Intervention: Nutrient formulation (Other)
Outcomes
Primary Outcomes
Incremental area under the blood glucose response cruve
Time Frame: 0-2 hours
Secondary Outcomes
- peak insulin(0-2 hours)
- peak blood glucose(0-2 hours)
Investigators
Study Sites (1)
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