Coronary Artery Disease
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFMD Arm
ProLon Fasting Mimicking Diet Plan
Sponsors
L-Nutra Inc
Hypertension Institute, Nashville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to End of Study in endothelial function | 7 months | Endothelial function will be measured for all subjects with EndoPAT and PulseWave noninvasive testing and laboratory analysis markers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline to End of Study in cardiovascular biomarkers | 7 months | Cardiovascular biomarkers will be measured for all subjects with serum lipid levels and serum inflammatory markers |
Countries
United States
Outcome results
None listed