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| Name | Class |
|---|---|
| L-Nutra Inc | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting Mimicking Diet (FMD) Arm | Experimental | 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. |
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| Mediterranean Diet Arm | Active Comparator | The Mediterranean diet is based on the traditional foods that people used to eat in countries like Italy and Greece in the 1960s.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FMD Arm | Dietary Supplement | ProLon Fasting Mimicking Diet Plan |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hypertension Institute | Nashville | Tennessee | 37205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38378685 | Derived | Brandhorst S, Levine ME, Wei M, Shelehchi M, Morgan TE, Nayak KS, Dorff T, Hong K, Crimmins EM, Cohen P, Longo VD. Fasting-mimicking diet causes hepatic and blood markers changes indicating reduced biological age and disease risk. Nat Commun. 2024 Feb 20;15(1):1309. doi: 10.1038/s41467-024-45260-9. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |