Evaluation of a Fasting Mimicking Diet

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT04150159

Run by

Hypertension Institute, Nashville

People needed

80

Starts

2019-03-01

Expected to finish

2020-01-31

Last updated by the study team

2020-07-31

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hypertension Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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