Evaluation of a Fasting Mimicking Diet

NCT ID: NCT04150159

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-01-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Fasting Mimicking Diet (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.

Group Type: EXPERIMENTAL

FMD Arm

Intervention Type: DIETARY_SUPPLEMENT

ProLon Fasting Mimicking Diet Plan

Mediterranean Diet 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.

Group Type: ACTIVE_COMPARATOR

FMD Arm

Intervention Type: DIETARY_SUPPLEMENT

ProLon Fasting Mimicking Diet Plan

Interventions

FMD Arm

ProLon Fasting Mimicking Diet Plan

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

L-Nutra Inc

INDUSTRY

Sponsor Role: collaborator

Hypertension Institute, Nashville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hypertension Institute

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

HTI 001

Identifier Type: -

Identifier Source: org_study_id