Water-only Fasting in the Treatment of Hypertension Patients
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ClinicalTrials.gov Identifier: NCT04515095 |
Recruitment Status :
Active, not recruiting
First Posted : August 17, 2020
Last Update Posted : June 1, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hypertension | Other: Water-only Fasting | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Safety and Feasibility Study of Water-only Fasting and Refeeding for Treatment of Stage 1 and 2 Hypertensive Patients |
Actual Study Start Date : | August 16, 2020 |
Actual Primary Completion Date : | September 29, 2021 |
Estimated Study Completion Date : | December 1, 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Water-only Fasting Group
Participants who voluntarily elect and are approved to water-only fast.
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Other: Water-only Fasting
Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision. |
- Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0 [ Time Frame: up to 10-60 days after baseline ]Adverse events will be identified through participant interviews and medical record review
- 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) [ 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 ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6-weeks after end of refeed ]Dietary adherence rates will be assessed using the SOS-free Dietary Screener
- Describe mean changes in resting blood pressure from baseline [ Time Frame: 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 ]Changes in SBP and diastolic blood pressure will be measured using a digital blood pressure device and reported as mmHg
- Describe mean changes in lipid profile from baseline [ Time Frame: 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 ]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
- Describe mean changes in fasting glucose and apolipoprotein B from baseline [ Time Frame: 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 ]Changes in fasting glucose and apolipoprotein B will be assessed using serum and reported as mg/dL
- Describe mean changes in body mass index (BMI) from baseline [ Time Frame: 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 ]Changes in BMI will be assessed by measuring weight in kilograms (kg) and height in meters (m) and reported as kg/m2
- Describe mean changes in insulin from baseline [ Time Frame: 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 ]Changes in insulin will be assessed by using serum and reported as uIU/ml
- Describe mean changes in visceral adipose tissue from baseline [ Time Frame: Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed ]Changes in visceral adipose tissue will be assessed using dual-energy X-ray absorptiometry and presented as grams
- Describe mean changes in high sensitivity C-reactive protein (hsCRP) from baseline [ Time Frame: 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 ]Changes in hsCRP will be assessed using serum and reported as mg/L
- Describe mean changes in gamma-glutamyl-transferase (GGT) from baseline [ Time Frame: 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 ]Changes in GGT will be assessed using serum and reported as U/L
- Describe mean changes in lipoprotein associated phospholipase A2 from baseline [ Time Frame: 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 ]Changes in lipoprotein associated phospholipase A2 will be assessed using serum and reported as nmol/min/mL
- Describe mean changes in homocysteine from baseline [ Time Frame: 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 ]Changes in homocysteine will be assessed using serum and reported as umol/L
- Describe mean changes in aldosterone from baseline [ Time Frame: 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 ]Changes in aldosterone will be assessed using serum and 24 hour urine and reported as ng/dL
- Describe mean changes in abdominal circumference from baseline [ Time Frame: 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 ]Abdominal circumference will be measured at minimal waist and reported in centimeters
- Describe changes in renin activity from baseline [ Time Frame: 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 ]Changes in renin activity will be assessed using serum and reported as ng/mL/hr
- Describe changes in sodium from baseline [ Time Frame: 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 ]Changes in sodium will be assessed using 24 hour urine and reported as mmol/24 hr
- Describe changes in creatinine and total protein from baseline [ Time Frame: 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 ]Changes in sodium will be assessed using 24 hour urine and reported as mg/dL
- Describe changes in potassium from baseline [ Time Frame: 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 ]Changes in potassium will be assessed using 24 hour urine and reported as mmol/L
- Describe changes in albumin from baseline [ Time Frame: 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 ]Changes in albumin will be assessed using 24 hour urine and reported as ug/mL
- Describe changes in 3-methyl-histidine from baseline [ Time Frame: Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed ]Changes in 3-methyl-histidine will be assessed using 24 hour urine and reported as umol/day

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515095
United States, California | |
TrueNorth Health Center | |
Santa Rosa, California, United States, 95404 |
Principal Investigator: | Toshia R Myers, PhD | Director |
Publications:
Responsible Party: | Toshia Myers, Director, TrueNorth Health Foundation |
ClinicalTrials.gov Identifier: | NCT04515095 |
Other Study ID Numbers: |
TNHF2020-1HTN |
First Posted: | August 17, 2020 Key Record Dates |
Last Update Posted: | June 1, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | After publication, the IPD will be available by contacting the corresponding author. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
fasting water-only fasting whole-plant-food diet |
Hypertension Vascular Diseases Cardiovascular Diseases |