PEP-1324: Glycemic Response Testing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Glycemic Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

A nutrient formulation without the active ingredient

Group Type PLACEBO_COMPARATOR

Nutrient formulation

Intervention Type OTHER

Nutrient formulation

Nutrient formulations with variable amounts of active ingredients.

Group Type EXPERIMENTAL

Nutrient formulation

Intervention Type OTHER

Interventions

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Nutrient formulation

Intervention Type OTHER

Eligibility Criteria

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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.