Water-only Fasting in the Treatment of Hypertension Patients

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515095
• Other study ID #: TNHF2020-1HTN
• Status: Completed
• Phase: N/A
• Start date: August 16, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2023
• Source: TrueNorth Health Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2022
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	TrueNorth Health Center	Santa Rosa	California

Sponsors (1)

Lead Sponsor	Collaborator
TrueNorth Health Foundation

Country where clinical trial is conducted

United States, 

References & Publications (47)

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* Note: There are 47 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Heart Disease Resource