Food Containing Resistant Starch Type 4 and Postprandial Glycemic Response

This is a single-center randomized, single-blinded, cross-over design study to allow for
three acute evaluations of 2 hr postprandial glucose in response to 3 cereal bars containing
different amounts of resistant starch. The study will evaluate acute glucose and insulin
response in healthy men and women aged 20-45 years.

The trial will initiate with record collection to assess background general health (screening
visit) and dietary intake followed by counseling to follow a relatively low polyphenolic
beverages/foods diet, and high fiber containing food (particularly fermentable) which will
commence at least 3 days before randomization (washout) and continue for the duration of the
study. After 3-day washout period, subjects will be randomized to treatment order within
Phase (Treatment cereal bars A, B, C). Glucose and insulin responses following the
consumption of cereal bars will be determined by blood collections via venous catheter. Blood
samples (3 ml of blood) will be collected at -5 min (before the cereal bar consumption) and
15, 30, 45, 60, 90, and 120 min after consuming bars for assessment in changes in glucose and
insulin concentrations in the plasma. The primary endpoint is glucose positive incremental
area under the curve (positive iAUC- ignores area below fasting) among the three tests bars.
Secondary endpoints are glucose peak, insulin positive iAUC and peak and glucose and insulin
net incremental AUC (net iAUC). Adverse events also will be collected and frequency
tabulated.

Inclusion Criteria:

- Subject is a male or female, 20-45 years of age, inclusive.

- Subject has a BMI of 20.0-24.9 kg/m2, inclusive and weight ≥ 110 lb. at screening
visit.

- Subject is willing to maintain his/her usual physical activity pattern throughout the
study period.

- Subject is willing to follow study instructions including compliance with dietary
restrictions, consumption of study bars, and study visit schedule.

- Subject is judged to be in good health on the basis of the medical history.

- Subject is willing to abstain from alcohol consumption for 24 hours prior to study
visit.

- Exercise to be maintained throughout study duration, including 3 days before study
visit

- Subject is willing to maintain a stable dose of current vitamins, minerals,
supplements and medications not interfering with study outcomes, including birth
control, throughout the study duration.

- Subject understands the study procedures and signs forms documenting informed consent
to participate in the study and authorization for release of relevant protected health
information to the study Investigator/s and is willing to complete study procedures.

Exclusion Criteria:

- Subject has fasting finger prick glucose >100 mg/dL.

- Subject has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic
blood pressure ≥100 mm Hg) at the screening visit.

- Subject has had major trauma or a surgical event within 2 months of study visit 1.

- Subject has had a weight change ≥4.5 kg within 2 months of visit, taking weight loss
drugs, or has had bariatric surgery or other weight reduction surgery (i.e.
liposuction, laser fat removal, etc)

- Subject has a history or presence of clinically important endocrine, cardiovascular
(including, but not limited to, atherosclerotic disease, history of myocardial
infarction, peripheral arterial disease, stroke), pulmonary, biliary, or
gastrointestinal disorders that, in the opinion of the Investigator, could interfere
with the interpretation of the study results.

- Subject has a history or presence of cancer in the prior 2 years, except for
non-melanoma skin cancer.

- Subject has a history of extreme dietary habits, as judged by the Investigator (e.g.,
Atkins diet, etc.).

- Subject has a history of an eating disorder (e.g., anorexia nervosa, bulimia nervosa,
or binge eating) diagnosed by a health professional.

- Subject has a known intolerance or sensitivity to any ingredients in the study
products.

- Subject has used medications known to influence carbohydrate metabolism, including,
but not limited to adrenergic blockers, diuretics, hypoglycemic medications, and
systemic corticosteroids 2 weeks prior to visit 1 and throughout the study.

- Subjects who used fiber supplements.

- Subject taking systemic steroids, extreme alcohol use, or drug user.

- Subject has vein access score less than 7.

- Subject is a female, who is pregnant, planning to be pregnant during the study period
or lactating.

- Subject is a current smoker. Past smoker abstinence for less than 2 years.

- Subject has participated in any clinical trial within 30 days prior to enrollment.