search
Back to results

Evaluation of a Fasting Mimicking Diet

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FMD Arm
Sponsored by
Hypertension Institute, Nashville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Hypertension Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fasting Mimicking Diet (FMD) Arm

Mediterranean Diet Arm

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2019
Last Updated
July 30, 2020
Sponsor
Hypertension Institute, Nashville
Collaborators
L-Nutra Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT04150159
Brief Title
Evaluation of a Fasting Mimicking Diet
Official Title
Evaluation of a Fasting Mimicking Diet and the Effect on Endothelial Function, Body Composition and Vascular Markers
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hypertension Institute, Nashville
Collaborators
L-Nutra Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fasting Mimicking Diet (FMD) Arm
Arm Type
Experimental
Arm 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.
Arm Title
Mediterranean Diet Arm
Arm Type
Active Comparator
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
FMD Arm
Intervention Description
ProLon Fasting Mimicking Diet Plan
Primary Outcome Measure Information:
Title
Change from Baseline to End of Study in endothelial function
Description
Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Change from Baseline to End of Study in cardiovascular biomarkers
Description
Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Hypertension Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of a Fasting Mimicking Diet

We'll reach out to this number within 24 hrs