Evaluation of a Fasting Mimicking Diet

Study Overview
=================
Brief Summary
-----------------
Randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months. Both arms will have a final study visit at month 7.

Detailed Description
-----------------
Determine the effects of the FMD on cardiovascular (CV) biomarkers, coronary heart disease (CHD) risk factors (body weight, body mass index (BMI), body composition, blood pressure, serum lipid levels and dysglycemia blood measurements), noninvasive cardiovascular testing for endothelial function, arterial stiffness of large and small arteries and autonomic function testing in adult subjects over a seven-month study period.

Official Title
-----------------
Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Dietary Supplement: FMD Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index equal to or greater than 28 EndoPAT® Score for endothelial function of less than or equal to 2.0 or AC 2 small resistance artery compliance by computerized arterial pulse wave analysis (CAPWA) of less than or equal to 5.0. Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Individuals who are allergic to tree nuts (macadamia, cashew, almond, pecan), soy, oats, sesame, or celery/celeriac Pregnant females Any cancer within the past 5 years Documented myocardial infarction within past 5 years Documented cerebrovascular accident within past 5 years Chronic steroid use (longer than 45 consecutive days Type I insulin-dependent diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, open-label, 7-month trial in eighty (80) adult subjects. Forty (40) subjects will be randomized to the intervention FMD arm with a 5 day meal program every month for four (4) months. Forty subjects will be randomized to a follow a Mediterranean diet plan for four months.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fasting Mimicking Diet (FMD) Arm<br>The ProLon® FMD diet is made up of nut bars, dehydrated soups, tea, olives, kale crackers, electrolyte beverages, and a chocolate crisp bar consumed for 5 days every 30 days for 4 months. | Dietary Supplement: FMD Arm<br>* ProLon Fasting Mimicking Diet Plan<br>|
| Active Comparator: Mediterranean Diet Arm<br>The Mediterranean diet is based on the traditional foods that people used to eat in countries like Italy and Greece in the 1960s. Eat every day: vegetables, fruits, nuts, seeds, legumes, potatoes, whole grains, breads, yogurt, dairy, fish/seafood, herbs, spices and extra virgin olive oil. Eat three or fewer servings each week: poultry, eggs, cheese. Eat two or fewer servings each week: red meat, potatoes. Eat two or fewer servings each week: sweets, sodas, processed meat, refined grains, refined oils and other highly processed foods. | Dietary Supplement: FMD Arm<br>* ProLon Fasting Mimicking Diet Plan<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to End of Study in endothelial function | Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline to End of Study in cardiovascular biomarkers | Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers | 7 months |