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Water-only Fasting in the Treatment of Hypertension Patients

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ClinicalTrials.gov Identifier: NCT04515095
Recruitment Status : Enrolling by invitation
First Posted : August 17, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Toshia Myers, TrueNorth Health Foundation

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

Condition or disease Intervention/treatment Phase
Hypertension Other: Water-only Fasting Phase 1 Phase 2

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, and 6-weeks post departure.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : August 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arms and Interventions
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Arm Intervention/treatment
Experimental: Water-only Fasting Group
Participants who voluntarily elect and are approved to water-only fast.
 Other: Water-only Fasting
Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]
    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 Outcome Measures:
  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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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


Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, California
TrueNorth Health Center
Santa Rosa, California, United States, 95404
Sponsors and Collaborators
TrueNorth Health Foundation
Investigators
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Principal Investigator: Toshia R Myers, PhD Director
More Information
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Additional Information:

Publications:
Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. Erratum in: Circulation. 2020 Jan 14;141(2):e33.
Forouzanfar MH, Liu P, Roth GA, Ng M, Biryukov S, Marczak L, Alexander L, Estep K, Hassen Abate K, Akinyemiju TF, Ali R, Alvis-Guzman N, Azzopardi P, Banerjee A, Bärnighausen T, Basu A, Bekele T, Bennett DA, Biadgilign S, Catalá-López F, Feigin VL, Fernandes JC, Fischer F, Gebru AA, Gona P, Gupta R, Hankey GJ, Jonas JB, Judd SE, Khang YH, Khosravi A, Kim YJ, Kimokoti RW, Kokubo Y, Kolte D, Lopez A, Lotufo PA, Malekzadeh R, Melaku YA, Mensah GA, Misganaw A, Mokdad AH, Moran AE, Nawaz H, Neal B, Ngalesoni FN, Ohkubo T, Pourmalek F, Rafay A, Rai RK, Rojas-Rueda D, Sampson UK, Santos IS, Sawhney M, Schutte AE, Sepanlou SG, Shifa GT, Shiue I, Tedla BA, Thrift AG, Tonelli M, Truelsen T, Tsilimparis N, Ukwaja KN, Uthman OA, Vasankari T, Venketasubramanian N, Vlassov VV, Vos T, Westerman R, Yan LL, Yano Y, Yonemoto N, Zaki ME, Murray CJ. Global Burden of Hypertension and Systolic Blood Pressure of at Least 110 to 115 mm Hg, 1990-2015. JAMA. 2017 Jan 10;317(2):165-182. doi: 10.1001/jama.2016.19043. Erratum in: JAMA. 2017 Feb 14;317(6):648.
Heidenreich PA, Trogdon JG, Khavjou OA, Butler J, Dracup K, Ezekowitz MD, Finkelstein EA, Hong Y, Johnston SC, Khera A, Lloyd-Jones DM, Nelson SA, Nichol G, Orenstein D, Wilson PW, Woo YJ; American Heart Association Advocacy Coordinating Committee; Stroke Council; Council on Cardiovascular Radiology and Intervention; Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Arteriosclerosis; Thrombosis and Vascular Biology; Council on Cardiopulmonary; Critical Care; Perioperative and Resuscitation; Council on Cardiovascular Nursing; Council on the Kidney in Cardiovascular Disease; Council on Cardiovascular Surgery and Anesthesia, and Interdisciplinary Council on Quality of Care and Outcomes Research. Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation. 2011 Mar 1;123(8):933-44. doi: 10.1161/CIR.0b013e31820a55f5. Epub 2011 Jan 24.

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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: August 18, 2020
Last Verified: August 2020
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Toshia Myers, TrueNorth Health Foundation:
fasting
water-only fasting
whole-plant-food diet
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases