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PEP-1324: Glycemic Response Testing

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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

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

Trial contacts and locations

1

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Central trial contact

Janice Campbell

Data sourced from clinicaltrials.gov

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