Glycemic Response Testing

PepsiCo

Status: Completed

Conditions: Glycemic Response

Treatments: Other: Dietary Intervention

Study type: Interventional

Funder types: Industry

Identifiers

NCT02020798

PEP-1328

Details and patient eligibility

About

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is 18-75 years of age
• Subject has a body mass index (BMI) ≥ 20.0 and < 35 kg/m² at screening (visit 1).
• Subject has normal fasting serum glucose (<7.0mmol/L capillary corresponding to whole blood glucose <6.3mmol/L).
• 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: Single Blind

---

38 participants in 2 patient groups, including a placebo group

Nutrient formulations without active ingredient

Placebo Comparator group

Description:

4 nutrient formulations without active ingredient and variable level of available placebo ingredient

Nutrient formulation with active ingredien

Experimental group

Description:

4 nutrient formulations with increasing amount of active ingredient

Treatment:

Other: Dietary Intervention