Clinical and Biochemical Effects of a Defined Plant-Based Diet on Heart Disease
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGeorgia State University
About this trial
A plant-based diet will be utilized in the treatment of coronary artery disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis with coronary artery disease (based on current EKG or prior diagnosis)
New patient
Disqualifiers
Current tobacco use
Current cancer diagnosis
An ongoing clinically defined infection
eGFR < 30
Trial design
Design model
Single group
Treatments tested in this trial
Nutritional intervention
Other interventionA plant-based diet
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Plant-based dietExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Improved endothelial function via reactive hyperemia index (RHI)
Peripheral microvascular function will be measured by PAT plethysmographic device (EndoPAT, Itamar®). The device consists of a finger probe with a transducer to assess digital volume changes accompanying pulse-waves. An inflatable cuff is placed on one arm (test arm), while amplitudes are recorded from the test arm and the contralateral control arm. Reactive hyperemia index (RHI) is obtained by the following: 5 minutes of baseline amplitude signal detection, 5 minutes of arterial occlusion by suprasystolic cuff inflation, and then 6 min of post-occlusion amplitude signal detection. RHI is a unit-less measure calculated as a ratio of hyperemic to baseline flow signal. It takes into account the baseline signal and adjusts it to the changes in the contralateral arm
Time frame
enrollment and at week 4Secondary outcomes
1
Arrythmia assessment
Ambulatory telemetric monitor will be used for a 14-day period to assess abnormal incidents of QRS complex waves. These abnormal incidents will be counted and quantified. This is an external devise that uses ECG electrodes.
Time frame
Weeks 1-2 and weeks 7-8.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Georgia State University
Lead sponsor
Johnsie and Aubary Montgomery Institute of Medical Education and Research
Collaborator
Source ClinicalTrials.gov