Evaluation of a Fasting Mimicking Diet

Hypertension Institute

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Dietary Supplement: FMD Arm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04150159

HTI 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Fasting Mimicking Diet (FMD) Arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: FMD Arm

Mediterranean Diet Arm

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: FMD Arm