Fiber Effects on Glycemic Index

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.

Each study visit will involve with blood samples collection at time points 0 (fasting), 0.5,
1, 2, 3 hour (h) for assessment of change in plasma glucose concentrations.

Inclusion Criteria:

- *Subject is male or female aged between 20 and 55 years of age

- Subject has BMI between 20.0 and 32.0 kg/m2 at the screening visit

- Fasting blood sugar less than 126 mg/dL

- Subject is willing to maintain a stable body weight and to follow his/her regular
diet and physical activity patterns throughout the study period.

- Subject is willing to refrain from vigorous physical activity and consumption of
alcoholic and/or caffeinated beverages 24 h prior to each test day

- Subject does not smoke or has abstained from smoking for at least 2 years

- No clinical evidence of cardiovascular, metabolic, respiratory, renal,
gastrointestinal or hepatic disease

- Not taking any medications or dietary supplements that would interfere with
outcomes of the study.

- Subject typically consumes a low fiber diet that correlates with the average
fiber intake of typical western diet.

Exclusion Criteria:

- *Subject currently smokes or has smoked within the past 2 years

- Men and women with known or suspected food intolerance, allergies or
hypersensitivity to the study materials or closely related compounds

- Men and women known to have/diagnosed with diabetes mellitus

- Men and women with a fasting blood glucose concentration ≥126 mg/dL

- Average blood pressure > 140 mmHg/90 mmHg during screening visit

- Men and women with documented vascular disease, e.g., heart failure, myocardial
infarction, stroke, angina, related surgeries

- Men and women with cancer other than non-melanoma skin cancer in previous 5 years

- Men and women who are taking medication or dietary supplements that may interfere
with the outcomes of the study. Subjects may choose to go off dietary supplements
(requires 30 days washout)