HYP-FAST trial study protocol: a phase II, single-center, open-label RCT comparing the effect of early time-restricted feeding on blood pressure control versus standard of care in individuals with primary hypertension

Abstract

: Background : Primary arterial hypertension is the most prevalent chronic disease globally and significantly impacts public health. It is hypothesized that 16:8 early time-restricted feeding (eTRF) bolsters blood pressure management. To date, there are no randomized trials evaluating its benefits in the treatment of hypertension as a primary outcome. Objective: To determine if eTRF combined with lifestyle modifications is superior to the standard lifestyle modifications treatment of primary hypertension recommended by the 2018 European hypertension guidelines. Methods: This will be a superiority, parallel, open-label, randomized, phase II trial carried out in a single center in Zurich, Switzerland. Participants between 30 and 60 years of age, recently diagnosed with high normal and grade I hypertension will be randomly assigned to the eTRF 18:6 plus lifestyle modifications group or the standard lifestyle interventions group. The primary outcome will be the difference between the mean systolic blood pressure at eight weeks with the baseline measurement. Discussion: This will be the first trial to evaluate the effects of intermittent fasting in patients with primary hypertension. Potential limitations include patient compliance to the intervention. However, in a previous study, self-reported adherence was observed in 1128 of 1351 participants (83.50%). In addition, this study seeks strategies to improve adherence. Conclusion: We hope that this trial directs other authors to carry out future studies aiming for higher external validity and evaluation of long-term effects of intermittent fasting for the treatment of primary hypertension.