Objective
A multinational food company needed to assess the safety and efficacy of rice vinegar as a treatment for pre-hypertensive adults, and those at high risk of Cardiovascular disease.
Methodology
This hybrid study collected clinical safety and efficacy data from a diverse population of patients with blood pressure of 120-139/80-89 mmHg. Emphasis was placed on ensuring representation of African American participants as this population over-indexes for high blood pressure. Between site visits, subjects completed daily questionnaires and chatted with the study team via the app, receiving daily reminders to report product compliance and health-related changes.
Results
• Successful recruitment of a diverse population: 41% Caucasian, 39% African American, 20% "other race."
• Minimization of site visits via remote monitoring, facilitated the collection of 56,286 data points which were reviewed in real time.
• The virtual team’s regular engagement with participants helped to achieve an 89% retention rate.
