Water-only Fasting in the Treatment of Hypertension Patients

TrueNorth Health Foundation

Status: Completed

Conditions: Hypertension

Treatments: Other: Water-only Fasting

Study type: Interventional

Funder types: Other

Identifiers

NCT04515095

TNHF2020-1HTN

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Water-only Fasting Group

Experimental group

Description:

Participants who voluntarily elect and are approved to water-only fast.

Treatment:

Other: Water-only Fasting