2.1. Experimental Design
hypertension
HYPERTENSION
The study was designed as a triple-blind, placebo-controlled, randomized parallel study to determine whether an optimized aged black garlic (ABG) extract could reduce systolic and diastolic blood pressure in subjects with Grade I hypertension. The study consisted of two periods. An initial period called the “Run-in phase”, two weeks in duration, involved all volunteers being treated with a placebo, and blood pressure was monitored daily and served as the basis for the evaluation of future changes in blood pressure. At least five consecutive days of home blood pressure monitoring are required for a reliable diagnosis of home hypertension [Volunteers were randomly assigned to each group by sequential number assignment, and they were divided by sex after their acceptance to participate in the study. The study was carried out under the ethical principles established in the latest version of the Declaration of Helsinki and Tokyo for human investigation and following Regulation (EU) 2016/679 of the European Parliament of the Council of 27 April 2016 on Data Protection (RGPD); Law 14/2007 on biomedical research; and Organic Law 3/2018 on the Protection of Personal Data and Guarantee of Digital Rights. Participants provided informed consent before they participated in the study. The study protocol was approved by Hospital Universitari Arnau de Vilanova (CEIC-2435), Lleida, Spain, and the trial is registered at ClinicalTrials.gov NCT04915053. No changes to methods after trial commencement were introduced.