PEP-1324: Glycemic Response Testing

PepsiCo

Status: Unknown

Conditions: Glycemic Response

Treatments: Other: Nutrient formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02037854

PEP-1324

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

A nutrient formulation without the active ingredient

Treatment:

Other: Nutrient formulation

Nutrient formulation

Experimental group

Description:

Nutrient formulations with variable amounts of active ingredients.

Treatment:

Other: Nutrient formulation