Verifying Fibers Meet Regulatory Definitions for Nutrition Facts Labeling: A Randomized, Controlled Trial Evaluating Polydextrose in Dry Form

This study is a randomized, 2-arm, single-blinded, controlled, cross-over trial design focused on determining the health benefits associated with Polydextrose intake.

A planned sample size of 20 will be enrolled into the study. This study will require one initial screening visit and 2 weekly study visits. This study will take approximately 2-3 weeks per subject to complete both 3-hr study visits on two different occasions.

The initial screening visit will provide subject with the informed consent document and determine subject eligibility through anthropometric measurements, vital signs, fasting blood glucose test (finger prick), and completion of a survey relate to general eating, health, and exercise habits.

If willing and eligible to participate, subjects will be invited to participate in the study for 2 study visits. Subjects will be instructed to maintain their usual diet pattern and physical activity throughout study duration. A dinner meal will be provided the day before the study visit to control the second meal effect from the food and beverage intake of the night before the study visit.

Subject will arrive at the center in a fasted state for at least 10 hours, well hydrated and rested. Each study visit will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a Licensed health Care Professional will place a catheter in subject's arm for the purpose of multiple blood sample collections and take the initial blood draw in the fasting state. Subjects will be randomized to receive a placebo or test food based on randomized treatment sequences for 2 study visits on two different occasions. The sequences of receiving the test food at each visit will be randomly assigned to one of sequences.