Back to resultsWater-only Fasting in the Treatment of Hypertension Patients
Primary Purpose
Hypertension
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Water-only Fasting
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring fasting, water-only fasting, whole-plant-food diet
Eligibility Criteria
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.
Sites / Locations
- TrueNorth Health Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Water-only Fasting Group
Arm Description
Participants who voluntarily elect and are approved to water-only fast.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Full Information
NCT ID
NCT04515095
First Posted
August 12, 2020
Last Updated
May 27, 2022
Sponsor
TrueNorth Health Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04515095
Brief Title
Water-only Fasting in the Treatment of Hypertension Patients
Official Title
A Safety and Feasibility Study of Water-only Fasting and Refeeding for Treatment of Stage 1 and 2 Hypertensive Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 16, 2020 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TrueNorth Health Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
fasting, water-only fasting, whole-plant-food diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Water-only Fasting Group
Arm Type
Experimental
Arm Description
Participants who voluntarily elect and are approved to water-only fast.
Intervention Type
Other
Intervention Name(s)
Water-only Fasting
Intervention Description
Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.
Primary Outcome Measure Information:
Title
Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0
Description
Adverse events will be identified through participant interviews and medical record review
Time Frame
up to 10-60 days after baseline
Secondary Outcome Measure Information:
Title
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)
Description
SBP will be measured using digital blood pressure device and reported in mmHg
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
Title
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on treatment acceptability
Description
Treatment acceptability will be assessed using the validated Treatment Adherence/Acceptability Questionnaire
Time Frame
Up to 7-40 days after baseline and 6-weeks after end of refeed
Title
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability
Description
Food acceptability will be assed using the validated Food Acceptability Questionnaire
Time Frame
6-weeks after end of refeed
Title
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece
Description
Dietary adherence rates will be assessed using the SOS-free Dietary Screener
Time Frame
6-weeks after end of refeed
Other Pre-specified Outcome Measures:
Title
Describe mean changes in resting blood pressure from baseline
Description
Changes in SBP and diastolic blood pressure will be measured using a digital blood pressure device and reported as mmHg
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
Title
Describe mean changes in lipid profile from baseline
Description
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
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
Title
Describe mean changes in fasting glucose and apolipoprotein B from baseline
Description
Changes in fasting glucose and apolipoprotein B will be assessed using serum and reported as mg/dL
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
Title
Describe mean changes in body mass index (BMI) from baseline
Description
Changes in BMI will be assessed by measuring weight in kilograms (kg) and height in meters (m) and reported as kg/m2
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
Title
Describe mean changes in insulin from baseline
Description
Changes in insulin will be assessed by using serum and reported as uIU/ml
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
Title
Describe mean changes in visceral adipose tissue from baseline
Description
Changes in visceral adipose tissue will be assessed using dual-energy X-ray absorptiometry and presented as grams
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
Title
Describe mean changes in high sensitivity C-reactive protein (hsCRP) from baseline
Description
Changes in hsCRP will be assessed using serum and reported as mg/L
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
Title
Describe mean changes in gamma-glutamyl-transferase (GGT) from baseline
Description
Changes in GGT will be assessed using serum and reported as U/L
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
Title
Describe mean changes in lipoprotein associated phospholipase A2 from baseline
Description
Changes in lipoprotein associated phospholipase A2 will be assessed using serum and reported as nmol/min/mL
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
Title
Describe mean changes in homocysteine from baseline
Description
Changes in homocysteine will be assessed using serum and reported as umol/L
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
Title
Describe mean changes in aldosterone from baseline
Description
Changes in aldosterone will be assessed using serum and 24 hour urine and reported as ng/dL
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
Title
Describe mean changes in abdominal circumference from baseline
Description
Abdominal circumference will be measured at minimal waist and reported in centimeters
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
Title
Describe changes in renin activity from baseline
Description
Changes in renin activity will be assessed using serum and reported as ng/mL/hr
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
Title
Describe changes in sodium from baseline
Description
Changes in sodium will be assessed using 24 hour urine and reported as mmol/24 hr
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
Title
Describe changes in creatinine and total protein from baseline
Description
Changes in sodium will be assessed using 24 hour urine and reported as mg/dL
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
Title
Describe changes in potassium from baseline
Description
Changes in potassium will be assessed using 24 hour urine and reported as mmol/L
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
Title
Describe changes in albumin from baseline
Description
Changes in albumin will be assessed using 24 hour urine and reported as ug/mL
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
Title
Describe changes in 3-methyl-histidine from baseline
Description
Changes in 3-methyl-histidine will be assessed using 24 hour urine and reported as umol/day
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshia R Myers, PhD
Organizational Affiliation
Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
TrueNorth Health Center
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication, the IPD will be available by contacting the corresponding author.
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https://www.cdc.gov/chronicdisease/resources/publications/factsheets/heart-disease-stroke.htm
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Heart Disease Resource
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Water-only Fasting in the Treatment of Hypertension Patients
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