Water-only Fasting in the Treatment of Hypertension Patients

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

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: Water-only Fasting

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Rosa, California, United States, 95404
      • TrueNorth Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Describe mean changes in resting blood pressure from baseline	Changes in SBP and diastolic blood pressure will be measured using a digital blood pressure device and reported as mmHg	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in lipid profile from baseline	Changes in lipid profile will be assessed using serum to measure cholesterol, triglycerides, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) and reported in mg/dL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in fasting glucose and apolipoprotein B from baseline	Changes in fasting glucose and apolipoprotein B will be assessed using serum and reported as mg/dL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in body mass index (BMI) from baseline	Changes in BMI will be assessed by measuring weight in kilograms (kg) and height in meters (m) and reported as kg/m2	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in insulin from baseline	Changes in insulin will be assessed by using serum and reported as uIU/ml	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in visceral adipose tissue from baseline	Changes in visceral adipose tissue will be assessed using dual-energy X-ray absorptiometry and presented as grams	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed
Describe mean changes in high sensitivity C-reactive protein (hsCRP) from baseline	Changes in hsCRP will be assessed using serum and reported as mg/L	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in gamma-glutamyl-transferase (GGT) from baseline	Changes in GGT will be assessed using serum and reported as U/L	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in lipoprotein associated phospholipase A2 from baseline	Changes in lipoprotein associated phospholipase A2 will be assessed using serum and reported as nmol/min/mL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in homocysteine from baseline	Changes in homocysteine will be assessed using serum and reported as umol/L	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in aldosterone from baseline	Changes in aldosterone will be assessed using serum and 24 hour urine and reported as ng/dL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe mean changes in abdominal circumference from baseline	Abdominal circumference will be measured at minimal waist and reported in centimeters	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in renin activity from baseline	Changes in renin activity will be assessed using serum and reported as ng/mL/hr	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in sodium from baseline	Changes in sodium will be assessed using 24 hour urine and reported as mmol/24 hr	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in creatinine and total protein from baseline	Changes in sodium will be assessed using 24 hour urine and reported as mg/dL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in potassium from baseline	Changes in potassium will be assessed using 24 hour urine and reported as mmol/L	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in albumin from baseline	Changes in albumin will be assessed using 24 hour urine and reported as ug/mL	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Describe changes in 3-methyl-histidine from baseline	Changes in 3-methyl-histidine will be assessed using 24 hour urine and reported as umol/day	Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed

Collaborators and Investigators

• Sponsor: TrueNorth Health Foundation
• Investigators: Principal Investigator: Toshia R Myers, PhD, Director

Publications and helpful links

General Publications

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Helpful Links

• Heart Disease Resource

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2020
• Primary Completion (Actual): September 29, 2021
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 14, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: fasting; water-only fasting; whole-plant-food diet
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: TNHF2020-1HTN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication, the IPD will be available by contacting the corresponding author.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No