Evaluation of a Fasting Mimicking Diet

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Dietary Supplement: FMD Arm

• Registration Number: NCT04150159
• Lead Sponsor: Hypertension Institute, Nashville

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.

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fasting Mimicking Diet (FMD) Arm	FMD Arm	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.
Mediterranean Diet Arm	FMD Arm	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline to End of Study in endothelial function	7 months	Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to End of Study in cardiovascular biomarkers	7 months	Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers

Trial Locations

Locations (1)

Hypertension Institute; 🇺🇸 Nashville, Tennessee, United States