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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
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.
Tópico:
Dietary Effects on Health
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FuentePrinciples and Practice of Clinical Research Journal