Evaluate the Effects of Repeated Periods of Modified Fasting to Support Healthy Natural Weight Management and Prevention of Weight Gain

This study is a randomized, placebo-controlled trial in which subjects assigned to the
modified fasting cohort will undergo consecutive weekly cycles of modified fasting for two
consecutive days.

The primary objective is to assess the effects of repeated periods of modified fasting on
body weight.

The secondary objectives include assessment of the effects of modified fasting on percent
body fat, waist circumference and fasting levels of hs-CRP (hs-C-reactive protein), IL-6
(Interleukin-6), IL-8 (interleukin-8), IL-12 (interleukin-12), TNF-a (tumor necrosis
factor-alpha), IGF-1 (insulin-like growth factor 1), IGFBP-1 (insulin-like growth
factor-binding protein 1) , Total Cholesterol, LDL cholesterol, HDL cholesterol, Glucose,
Triglyceride, Insulin, Vitamin-D, 25-Hydroxy,

Participants will undergo assessments of blood tests, vital signs, BMI, body weight, waist
circumference and percent body fat.

Inclusion Criteria:

- Ambulatory, male or female, 21-65 years of age

- A body mass index (BMI) of 23‒34.9

- Generally healthy and having no significant difficulty with digestion of food

- Has been generally weight stable for the past six months

- Willing to discontinue use of any (non-study) multivitamin or Vitamin D supplements
during the study

- Willing and able to give written informed consent

- Clearly understands the procedures and study requirements

- Willing and able to comply with all study procedures, including following the
recommendations to maintain their usual diet and regular activity, as per protocol

- Able to communicate, including reading, in English

Primary Exclusion Criteria:

- Having smoked any cigarette, electronic cigarette, cigar, pipe, or used a recreational
drug in the past 30 days

- History of allergy or sensitivity to any component of the study products including
milk, soy and almonds

- Donation of blood with 30 days prior to screening/baseline

- Inability to provide a venous blood sample

- Participation in another study within 30 days prior to baseline/screening

- Being pregnant or planning on becoming pregnant during study participation; or breast
feeding

- Having been diagnosed, received medical treatment or taking medication daily for the
following medical condition(s):

- Diabetes mellitus

- Eating disorder

- Acute or chronic inflammatory disease or autoimmune disease

- Cardiovascular disease

- Gastrointestinal disease including gallbladder problems, gallstones or biliary tract
obstruction

- Thyroid disease (unless on a stable dose of medication for 3 months prior to screening
and unlikely to change medication or dose during the study)

- Hypertension (unless on a stable dose of medication for 3 months prior to screening
and unlikely to change medication or dose during the study)

- Psychiatric disorder

- Neurologic condition/disease

- Cancer (unless skin cancer other than melanoma which has been treated > 3 years prior
to Baseline/screening)

- Active or chronic liver, pancreatic and kidney disease

- Blood coagulation disorder

- Other condition or medication use that would preclude participation in the study in
the judgment of the investigator/sub-investigator (Sub-I)

- Currently taking or having taken within the 30 days prior to screening/baseline any
hormone replacement therapy (including DHEA (dehydroepiandrosterone), estrogen,
progesterone, or testosterone; except those utilized as a method of birth control and
which have been taken for > 3 months, with no anticipated change for the duration of
the study)

- Currently taking any of the nutritional supplements used in the study and unwilling to
discontinue use at least 14 days prior to screening.

- Currently taking a medication or nutritional supplement specifically for weight loss
and unwilling to discontinue use 14 days prior to the first dosing of study
supplements

- Currently participating in a weight loss program and unwilling to discontinue
participation prior to enrollment into the study

- Currently taking an anti-coagulant, anti-platelet medication or a glucose lowering
medication

- Having had a surgical procedure or having an internal medical device which, in the
judgment of the PI/Sub-I, would preclude participation in the study

- Having abnormal screening laboratory test values including bilirubin > 2.5 x ULN
(upper limit of normal), AST/SGOT(aspartate aminotransferase/serum glutamin
oxaloacetic transaminase) and ALT/SGPT (alanine aminotransferase/serum glutamic
pyruvic transaminase) > 2.5 x ULN, serum creatinine > 1.5 mg/dL, blood glucose < 85
mg/dL or > 125 mg/dL, and TSH(thyroid stimulating hormone) > 4.12 µIU/mL, or other lab
test result(s) that would preclude study participation in the judgement of the
PI/Sub-I

- Having blood pressure readings at Baseline/screening > 140 systolic or > 90 diastolic
on two consecutive readings unless permitted to proceed to the next visit in the
judgment of the PI/Sub-I

- Currently consumes more than 7 standard alcoholic drinks per week for women and 14
drinks per week for men (a standard alcoholic drink is defined as one bottle/can of
beer, one glass of wine, or one ounce of hard liquor)

- Unable or unwilling to avoid consuming grapefruit juice or fresh grapefruit, Seville
oranges and tangelos

- Having any other circumstance that precludes study participation in the judgment of
the PI/Sub-I including use of other nutritional supplements which will be evaluated on
a case-by-case basis.