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Completed

NCT Number: NCT04515095

Water-only Fasting in the Treatment of Hypertension Patients

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

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Key information

Conditions

Hypertension Behavior Cardiovascular Diseases Fasting Feeding Behavior Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TrueNorth Health Center

Santa Rosa, California, 95404, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Water-only Fasting

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

TrueNorth Health Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Aug 17, 2020
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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