Weekly ONe-Day WatER-only Fasting InterventionaL Trial for Low-Density Lipoprotein Cholesterol Reduction

Inclusion Criteria:

1. Male or non-pregnant female, 21-70 years of age,

- who are not currently taking a statin medication,

- who have either pre-diabetes (clinical diagnosis, hemoglobin A1c ≥5.6%, or
untreated fasting glucose > 100 mg/dL within 6 months of screening) and are not
taking medications to control diabetes OR diagnosed, diet-controlled type 2
diabetes but do not require medications to control diabetes OR one or more of the
components of the metabolic syndrome measured within 6 months of screening (other
than fasting glucose level >100 mg/dL, i.e.: 1. systolic blood pressure ≥130
mmHg, or diastolic ≥85 mmHg, or use of an antihypertensive medication, 2.
high-density lipoprotein cholesterol <40 mg/dL for males or <50 mg/dL for
females, 3. triglycerides ≥150 mg/dL or use of a non-statin triglyceride-lowering
medication (e.g., fibrate, niacin), 4. waist circumference ≥40 inches (102 cm)
for males or ≥35 inches (88 cm) for females, or body mass index >25 kg/m2),

- are 21-39 years of age with LDL-C (measured within six months of screening) of
90-189 mg/dL OR are 40-70 years of age with LDL-C of 90-159 mg/dL OR are 21-70
years of age with LDL-C of 90 mg/dL or greater who have tried statins and stopped
due to intolerance to the medications or who have one or more contraindications
to statins and thus cannot take them but meet other study inclusion and exclusion
criteria.

2. Ability to understand and sign a written informed consent form, which must be obtained
prior to initiation of any study procedures.

Exclusion Criteria:

1. Pregnant and/or lactating women and women of child bearing potential who are not using
acceptable means of contraception. Women who become pregnant after enrollment in the
study will be withdrawn for the health of the mother and baby.

2. Individuals who have fasted more than 15 hours per episode more than once per month
during the past two years (i.e., >720 hours over two years), except for those who fast
during multiple weeks once per year (e.g., Muslim, Baha'i) who will be allowed to
begin participation starting at two weeks after their preferred annual period of
fasting ends (e.g., Ramadan or the Baha'i fast) and ending at six months prior to the
beginning of the next annual observance, as long as they do not fast routinely outside
of the one annual period of fasting.

3. Refusal to drink water while fasting.

4. Prior diagnosis of a chronic disease (i.e., defined as symptomatic coronary artery
disease, coronary revascularization, myocardial infarction, unstable angina, stroke,
transient ischemic attack, pulmonary embolism, peripheral vascular thromboembolism,
chronic kidney disease stage III or higher, chronic obstructive pulmonary disease,
immunodeficiency, solid organ transplant, eating disorder, type I diabetes, dementia,
traumatic brain injury including post-concussive syndrome, and cancer of any type
within the last 5 years other than cancer of the skin excluding melanoma).

5. Pre-diabetics or diabetics on diabetes medication.

6. Participation in any other clinical trials involving investigational or marketed
products within 30 days prior to entry in the study.

7. Other conditions that in the opinion of the Principal Investigator may increase risk
to the subject and/or compromise the quality of the clinical trial.