An interventional study of FMD Arm in Coronary Artery Disease, sponsored by Hypertension Institute, Nashville. Completed at 1 site in United States. Open to participants aged 35 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-31.
Sponsored by Hypertension Institute, Nashville · Not applicable, Interventional, and Prevention
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 80 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Hypertension Institute, Nashville is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: 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.
Dietary Supplement: FMD Arm
ProLon Fasting Mimicking Diet Plan
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
Time frame: 7 months
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
Time frame: 7 months
Plan to share: No
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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Hypertension Institute, Nashville