Water-only Fasting in the Treatment of Hypertension Patients

Study Overview
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Brief Summary
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This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.

Detailed Description
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This is a prospective, open label, single arm, intervention study to examine the safety and feasibility of water-only fasting to treat hypertensive patients. Additional aims include describing mean changes in resting blood pressure as well as markers of cardiovascular health and inflammation between baseline and end of fast, end of refeed, 6-weeks post departure, and 12-months after 6-weeks follow-up.

Official Title
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A Safety and Feasibility Study of Water-only Fasting and Refeeding for Treatment of Stage 1 and 2 Hypertensive Patients

Conditions
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Hypertension

Intervention / Treatment
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* Other: Water-only Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any gender 30-75 years old Diagnosis of Stage 1 or 2 hypertension Fasting plasma glucose <126mg/dL and/or hemoglobin A1c <7 percent Elect and qualify for a water-only fast of at least 7 consecutive days Provide informed consent Internet and computer access Able to go to LabCorp for 6-week follow-up visit Willing/able to collect 24-hour urine sample prior to water-only fasting Exclusion Criteria: Systolic Blood Pressure/Diastolic Blood Pressure >180/120 mmHg Active malignancy Active kidney disease (creatinine over 2.0) Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's) Stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months Inability to discontinue medications or supplements Abdominal metal implants Inability to consume only plant food for at least 48 hours before fast begins. Unable to lay still on the back for at least 10 min.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Water-only Fasting Group<br>Participants who voluntarily elect and are approved to water-only fast. | Other: Water-only Fasting<br>* Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0 | Adverse events will be identified through participant interviews and medical record review | up to 10-60 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on change in systolic blood pressure (SBP) | SBP will be measured using digital blood pressure device and reported in mmHg | Baseline, up to 10 to 40 days after baseline, up to 5 to 20 days after end of fast, 6-weeks after departure, 12-months after 6-weeks follow-up | 
| Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on treatment acceptability | Treatment acceptability will be assessed using the validated Treatment Adherence/Acceptability Questionnaire | Up to 7-40 days after baseline and 6-weeks after end of refeed | 
| Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability | Food acceptability will be assed using the validated Food Acceptability Questionnaire | 6-weeks after end of refeed | 
| Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece | Dietary adherence rates will be assessed using the SOS-free Dietary Screener | 6-weeks after end of refeed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fasting, water-only fasting, whole-plant-food diet