Water-only Fasting in the Treatment of Hypertension Patients

NCT04515095 | Completed

• 1 other identifier: TNHF2020-1HTN
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypertension

Keywords

fasting; water-only fasting; whole-plant-food diet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Other Outcomes (18)

• Describe mean changes in resting blood pressure from baseline

  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

  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

  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

Study Arms (1)

Water-only Fasting Group

EXPERIMENTAL

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

Other: Water-only Fasting

Interventions

Water-only Fasting OTHER

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

Water-only Fasting Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any gender
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TrueNorth Health Foundation: lead

Study Sites (1)

TrueNorth Health Center

Santa Rosa, California, 95404, United States

Location

Related Publications (48)

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  PMID: 39599745 DERIVED

MeSH Terms

Conditions

Hypertension; Fasting

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Feeding Behavior; Behavior

Study Officials

• Toshia R Myers, PhD

  Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 17, 2020
• Study Start: August 16, 2020
• Primary Completion: September 29, 2021
• Study Completion: December 1, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)