Water-only Fasting in the Treatment of Hypertension Patients
- Conditions
- Hypertension
- Interventions
- Other: Water-only Fasting
- Registration Number
- NCT04515095
- Lead Sponsor
- TrueNorth Health Foundation
- Brief Summary
This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Water-only Fasting Group Water-only Fasting Participants who voluntarily elect and are approved to water-only fast.
- Primary Outcome Measures
Name Time Method Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0 up to 10-60 days after baseline Adverse events will be identified through participant interviews and medical record review
- Secondary Outcome Measures
Name Time Method 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) 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 SBP will be measured using digital blood pressure device and reported in mmHg
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on treatment acceptability Up to 7-40 days after baseline and 6-weeks after end of refeed Treatment acceptability will be assessed using the validated Treatment Adherence/Acceptability Questionnaire
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability 6-weeks after end of refeed Food acceptability will be assed using the validated Food Acceptability Questionnaire
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece 6-weeks after end of refeed Dietary adherence rates will be assessed using the SOS-free Dietary Screener
Trial Locations
- Locations (1)
TrueNorth Health Center
🇺🇸Santa Rosa, California, United States