Skip to main content
OpenTrials
Completed

NCT Number: NCT04150159

Evaluation of a Fasting Mimicking Diet

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hypertension Institute

Nashville, Tennessee, 37205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FMD Arm

Dietary Supplement

ProLon Fasting Mimicking Diet Plan

Primary outcomes

  1. Change from Baseline to End of Study in endothelial function

    Time frame: 7 months

    Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers

Secondary outcomes

  1. Change from Baseline to End of Study in cardiovascular biomarkers

    Time frame: 7 months

    Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers

Sponsors and collaborators

Lead sponsor

Hypertension Institute, Nashville

Other

Collaborators

  • L-Nutra Inc

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 4, 2019
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.