Prolonged Water-only Fasting is a Safe and Feasible Treatment Option for Managing Stage 1 and 2 Hypertension

medrxiv(2024)

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摘要
Prolonged water-only fasting appears to reduce high blood pressure but randomized controlled trials are needed. This single arm pre-post interventional trial ([clinicaltrials.gov][1], [NCT04515095][2]) investigates the safety, feasibility, and effectiveness of prolonged water-only fasting in the treatment of stage 1 and 2 hypertension. Twenty-nine participants with stage 1 and 2 hypertension, who were pre-approved to water-only fast for ≥7 days, were enrolled from a residential fasting center. Participants received 24-hour medical supervision, and adverse events were recorded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Feasibility was assessed based on retention rate, ability to complete minimal fast length, and intervention acceptability. Demographic, anthropometric, medication use, laboratory, and survey data were also collected. Twenty-seven of the 29 enrolled participants attended all study visits through the six-week follow-up visit and completed at least seven consecutive days of water-only fasting. The majority of adverse events were mild and transient and there were no higher-grade or serious adverse events. Overall, the intervention was acceptable. At the six-week follow-up visit, there were sustained reductions in median systolic/diastolic blood pressure (−19.19/-5.13 mmHg), body weight (−6.72 kg), abdominal circumference, −6.55 cm), and anti-hypertensive medication use (−93%), which also persisted at the 12-month follow-up visit. These preliminary data suggest that prolonged water-only fasting is a safe and feasible treatment option for stage 1 and 2 hypertension. The data also suggest that fasting may result in sustainable reductions in high blood pressure and anti-hypertensive medication use. ### Competing Interest Statement ACG is the owner of the TrueNorth Health Center and President of the Board of Directors of the TrueNorth Health Foundation. All other authors declare no conflict of interest. ### Clinical Trial NCT04515095 ### Funding Statement This study was conducted by the TrueNorth Health Foundation and did not receive any funding. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board of the TrueNorth Health Foundation (TNHF2020-1HTN, August 16, 2020 and TNHF2021-1HTNFU, October 28, 2021). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data is available upon request to the corresponding author. * BL : Baseline EOF : End of fast EOR : End of refeed FAQ : Food Acceptability Questionnaire FU : Follow up SOS : Salt, oil, and sugar TAAS : Treatment Adherence/Acceptability Scale VB : Vegetable Broth [1]: http://clinicaltrials.gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04515095&atom=%2Fmedrxiv%2Fearly%2F2024%2F02%2F05%2F2024.02.04.24302309.1.atom
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