Evaluation of a Fasting Mimicking Diet

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04150159
• Other study ID #: HTI 001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: July 2020
• Source: Hypertension Institute, Nashville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Dietary Supplement:
• FMD Arm
ProLon Fasting Mimicking Diet Plan

Locations

Country	Name	City	State
United States	Hypertension Institute	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Hypertension Institute, Nashville	L-Nutra Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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