Postprandial Glycemia in Apple Products

This study is a randomized, 3-arm, within subject cross-over trial allowing for three acute
evaluations of 100% Apple Juice (235 g), 100% Apple Juice with enzyme-treated apple pomace
fiber (129 g apple juice with 106 g apple pomace), and raw apple (230 g with skin edible
portion - not including core or stem) on glucose and insulin responses in fifty-two healthy
men and women aged 20-45 years.

A planned sample size of 70 will be enrolled into the study. This study will require one
initial screening visit and 3 study visits. This study will take approximately 3-4 weeks per
subject to complete.

The initial screening visit will take ~2 hours and provide subject with the informed consent
document and determine subject eligibility through anthropometric measurements, body
composition measurement, vital signs, fasting blood glucose test (finger prick), a vein
access scale evaluation, online 24-hr diet recall, and completion of a survey relate to
general eating, health, and exercise habits. For women, a pregnancy test will be conducted.

If willing and eligible to participate, subjects will be invited to participate in the study
for 3 study day visits. Eligible subjects will be instructed to follow a relatively low
polyphenolic diet for at least 1-week prior the beginning of the study and continue for the
duration of the study.

Each Study Day visit will last about ~3 hours. The day before each of the 3 Study Day visits,
subjects will be asked to consume the same dinner meal and record on a food record. At each
Study Day visit, subjects will arrive at the clinic after fasting for 10 to 12 hours and in a
well-hydrated and well-rested state.

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 one of study products based on
randomized treatment sequences for 3 study visits immediately after fasting blood draw.

Participants will come to the research site on 3 separate occasions separated by a washout
period. On each occasion 2 fasting blood samples will be obtained at 5 min intervals (-5, 0
minute (min)). Subjects will then consume one of the 3 treatments. Further blood samples will
be taken at 15, 25, 30, 35, 40, 45, 60, 75, 90, 105 and 120 min. Self-reported visual analog
scales (VAS) will be used to measure subject hunger, fullness, desire to eat, and prospective
food intake at 0, 15, 30, 60, 90, and 120 min. After completion of all study procedures and
data/sample collection for the day, the catheter will be removed and subjects will be
evaluated for safety and/or discomfort/symptoms before leaving the study site. They will be
given a take-home snack and given written instructions in preparation for the next visit.
Study day visits will be scheduled at least 3 days apart but no more than 7 days.

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 beverage, 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 stable dose of current vitamins, minerals,
supplements and medications not interfering with study outcomes, including birth
control, throughout 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 (ie.
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.

- 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 30d prior to enrollment.

- No participation in another Sponsored protocol within 6 months prior to
enrollment