Water-only Fasting in the Treatment of Hypertension Patients

TrueNorth Health Foundation30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Water-only FastingOTHER

Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Any gender 2. 30-75 years old 3. Diagnosis of Stage 1 or 2 hypertension 4. Fasting plasma glucose \<126mg/dL and/or hemoglobin A1c \<7 percent 5. Elect and qualify for a water-only fast of at least 7 consecutive days 6. Provide informed consent 7. Internet and computer access 8. Able to go to LabCorp for 6-week follow-up visit 9. Willing/able to collect 24-hour urine sample prior to water-only fasting Exclusion Criteria: 1. Systolic Blood Pressure/Diastolic Blood Pressure \>180/120 mmHg 2. Active malignancy 3. Active kidney disease (creatinine over 2.0) 4. Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's) 5. Stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months 6. Inability to discontinue medications or supplements 7. Abdominal metal implants 8. Inability to consume only plant food for at least 48 hours before fast begins. 9. Unable to lay still on the back for at least 10 min.

Locations (1)

TrueNorth Health Center

Santa Rosa, California, United States

Outcomes

Primary Outcomes

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

Time frame: up to 10-60 days after baseline

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6-weeks after end of refeed

Data from ClinicalTrials.gov

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