Water-only Fasting in the Treatment of Hypertension Patients

NCT ID: NCT04515095

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-16
• Study Completion Date: 2022-12-01

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.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Water-only Fasting Group

Participants who voluntarily elect and are approved to water-only fast.

Group Type: EXPERIMENTAL

Water-only Fasting

Intervention Type: OTHER

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

Interventions

Water-only Fasting

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrueNorth Health Foundation

OTHER

Sponsor Role: lead

Responsible Party

Toshia Myers

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Toshia R Myers, PhD

Role: PRINCIPAL_INVESTIGATOR

Director

Locations

TrueNorth Health Center

Santa Rosa, California, United States

Countries

United States

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 30700139 (View on PubMed)

Rapsomaniki E, Timmis A, George J, Pujades-Rodriguez M, Shah AD, Denaxas S, White IR, Caulfield MJ, Deanfield JE, Smeeth L, Williams B, Hingorani A, Hemingway H. Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1.25 million people. Lancet. 2014 May 31;383(9932):1899-911. doi: 10.1016/S0140-6736(14)60685-1.

Reference Type: BACKGROUND

PMID: 24881994 (View on PubMed)

Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet. 2002 Dec 14;360(9349):1903-13. doi: 10.1016/s0140-6736(02)11911-8.

Reference Type: BACKGROUND

PMID: 12493255 (View on PubMed)

Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

Reference Type: BACKGROUND

PMID: 29146535 (View on PubMed)

Chockalingam A, Campbell NR, Fodor JG. Worldwide epidemic of hypertension. Can J Cardiol. 2006 May 15;22(7):553-5. doi: 10.1016/s0828-282x(06)70275-6.

Reference Type: BACKGROUND

PMID: 16755308 (View on PubMed)

Franklin SS. Ageing and hypertension: the assessment of blood pressure indices in predicting coronary heart disease. J Hypertens Suppl. 1999 Dec;17(5):S29-36.

Reference Type: BACKGROUND

PMID: 10706323 (View on PubMed)

Wall HK, Hannan JA, Wright JS. Patients with undiagnosed hypertension: hiding in plain sight. JAMA. 2014 Nov 19;312(19):1973-4. doi: 10.1001/jama.2014.15388. No abstract available.

Reference Type: BACKGROUND

PMID: 25399269 (View on PubMed)

Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.

Reference Type: BACKGROUND

PMID: 15053002 (View on PubMed)

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, Barnighausen T, Basu A, Bekele T, Bennett DA, Biadgilign S, Catala-Lopez 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.

Reference Type: BACKGROUND

PMID: 28097354 (View on PubMed)

SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9.

Reference Type: BACKGROUND

PMID: 26551272 (View on PubMed)

Kirkland EB, Heincelman M, Bishu KG, Schumann SO, Schreiner A, Axon RN, Mauldin PD, Moran WP. Trends in Healthcare Expenditures Among US Adults With Hypertension: National Estimates, 2003-2014. J Am Heart Assoc. 2018 May 30;7(11):e008731. doi: 10.1161/JAHA.118.008731.

Reference Type: BACKGROUND

PMID: 29848493 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21262990 (View on PubMed)

Ames MK, Atkins CE, Pitt B. The renin-angiotensin-aldosterone system and its suppression. J Vet Intern Med. 2019 Mar;33(2):363-382. doi: 10.1111/jvim.15454. Epub 2019 Feb 26.

Reference Type: BACKGROUND

PMID: 30806496 (View on PubMed)

Buglioni A, Cannone V, Sangaralingham SJ, Heublein DM, Scott CG, Bailey KR, Rodeheffer RJ, Sarzani R, Burnett JC. Aldosterone Predicts Cardiovascular, Renal, and Metabolic Disease in the General Community: A 4-Year Follow-Up. J Am Heart Assoc. 2015 Dec 23;4(12):e002505. doi: 10.1161/JAHA.115.002505.

Reference Type: BACKGROUND

PMID: 26702078 (View on PubMed)

Cannone V, Buglioni A, Sangaralingham SJ, Scott C, Bailey KR, Rodeheffer R, Redfield MM, Sarzani R, Burnett JC Jr. Aldosterone, Hypertension, and Antihypertensive Therapy: Insights From a General Population. Mayo Clin Proc. 2018 Aug;93(8):980-990. doi: 10.1016/j.mayocp.2018.05.027.

Reference Type: BACKGROUND

PMID: 30077215 (View on PubMed)

Dudenbostel T, Calhoun DA. Use of Aldosterone Antagonists for Treatment of Uncontrolled Resistant Hypertension. Am J Hypertens. 2017 Feb;30(2):103-109. doi: 10.1093/ajh/hpw105. Epub 2016 Sep 8.

Reference Type: BACKGROUND

PMID: 27609503 (View on PubMed)

Bronsert MR, Henderson WG, Valuck R, Hosokawa P, Hammermeister K. Comparative effectiveness of antihypertensive therapeutic classes and treatment strategies in the initiation of therapy in primary care patients: a Distributed Ambulatory Research in Therapeutics Network (DARTNet) study. J Am Board Fam Med. 2013 Sep-Oct;26(5):529-38. doi: 10.3122/jabfm.2013.05.130048.

Reference Type: BACKGROUND

PMID: 24004705 (View on PubMed)

Wright JM, Musini VM, Gill R. First-line drugs for hypertension. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD001841. doi: 10.1002/14651858.CD001841.pub3.

Reference Type: BACKGROUND

PMID: 29667175 (View on PubMed)

Gebreyohannes EA, Bhagavathula AS, Abebe TB, Tefera YG, Abegaz TM. Adverse effects and non-adherence to antihypertensive medications in University of Gondar Comprehensive Specialized Hospital. Clin Hypertens. 2019 Jan 15;25:1. doi: 10.1186/s40885-018-0104-6. eCollection 2019.

Reference Type: BACKGROUND

PMID: 30675379 (View on PubMed)

Gupta R, Guptha S. Strategies for initial management of hypertension. Indian J Med Res. 2010 Nov;132(5):531-42.

Reference Type: BACKGROUND

PMID: 21150005 (View on PubMed)

Siervo M, Lara J, Chowdhury S, Ashor A, Oggioni C, Mathers JC. Effects of the Dietary Approach to Stop Hypertension (DASH) diet on cardiovascular risk factors: a systematic review and meta-analysis. Br J Nutr. 2015 Jan 14;113(1):1-15. doi: 10.1017/S0007114514003341. Epub 2014 Nov 28.

Reference Type: BACKGROUND

PMID: 25430608 (View on PubMed)

Chiavaroli L, Viguiliouk E, Nishi SK, Blanco Mejia S, Rahelic D, Kahleova H, Salas-Salvado J, Kendall CW, Sievenpiper JL. DASH Dietary Pattern and Cardiometabolic Outcomes: An Umbrella Review of Systematic Reviews and Meta-Analyses. Nutrients. 2019 Feb 5;11(2):338. doi: 10.3390/nu11020338.

Reference Type: BACKGROUND

PMID: 30764511 (View on PubMed)

Grillo A, Salvi L, Coruzzi P, Salvi P, Parati G. Sodium Intake and Hypertension. Nutrients. 2019 Aug 21;11(9):1970. doi: 10.3390/nu11091970.

Reference Type: BACKGROUND

PMID: 31438636 (View on PubMed)

McDougall J, Thomas LE, McDougall C, Moloney G, Saul B, Finnell JS, Richardson K, Petersen KM. Effects of 7 days on an ad libitum low-fat vegan diet: the McDougall Program cohort. Nutr J. 2014 Oct 14;13:99. doi: 10.1186/1475-2891-13-99.

Reference Type: BACKGROUND

PMID: 25311617 (View on PubMed)

McDougall J, Thomas LE, McDougall C, Moloney G, Saul B, Finnell JS, Richardson K, Petersen KM. Erratum to: Effects of 7 days on an ad libitum low-fat vegan diet: the McDougall Program cohort. Nutr J. 2017 Feb 10;16(1):12. doi: 10.1186/s12937-017-0234-9. No abstract available.

Reference Type: BACKGROUND

PMID: 28187767 (View on PubMed)

Huang L, Trieu K, Yoshimura S, Neal B, Woodward M, Campbell NRC, Li Q, Lackland DT, Leung AA, Anderson CAM, MacGregor GA, He FJ. Effect of dose and duration of reduction in dietary sodium on blood pressure levels: systematic review and meta-analysis of randomised trials. BMJ. 2020 Feb 24;368:m315. doi: 10.1136/bmj.m315.

Reference Type: BACKGROUND

PMID: 32094151 (View on PubMed)

Beauchesne AB, Goldhamer AC, Myers TR. Exclusively plant, whole-food diet for polypharmacy due to persistent atrial fibrillation, ischaemic cardiomyopathy, hyperlipidaemia and hypertension in an octogenarian. BMJ Case Rep. 2018 Dec 17;11(1):e227059. doi: 10.1136/bcr-2018-227059.

Reference Type: BACKGROUND

PMID: 30567282 (View on PubMed)

Tuso PJ, Ismail MH, Ha BP, Bartolotto C. Nutritional update for physicians: plant-based diets. Perm J. 2013 Spring;17(2):61-6. doi: 10.7812/TPP/12-085.

Reference Type: BACKGROUND

PMID: 23704846 (View on PubMed)

Esselstyn CB. A plant-based diet and coronary artery disease: a mandate for effective therapy. J Geriatr Cardiol. 2017 May;14(5):317-320. doi: 10.11909/j.issn.1671-5411.2017.05.004. No abstract available.

Reference Type: BACKGROUND

PMID: 28630609 (View on PubMed)

Goldhamer A, Lisle D, Parpia B, Anderson SV, Campbell TC. Medically supervised water-only fasting in the treatment of hypertension. J Manipulative Physiol Ther. 2001 Jun;24(5):335-9. doi: 10.1067/mmt.2001.115263.

Reference Type: BACKGROUND

PMID: 11416824 (View on PubMed)

Finnell JS, Saul BC, Goldhamer AC, Myers TR. Is fasting safe? A chart review of adverse events during medically supervised, water-only fasting. BMC Complement Altern Med. 2018 Feb 20;18(1):67. doi: 10.1186/s12906-018-2136-6.

Reference Type: BACKGROUND

PMID: 29458369 (View on PubMed)

Tchkonia T, Thomou T, Zhu Y, Karagiannides I, Pothoulakis C, Jensen MD, Kirkland JL. Mechanisms and metabolic implications of regional differences among fat depots. Cell Metab. 2013 May 7;17(5):644-656. doi: 10.1016/j.cmet.2013.03.008. Epub 2013 Apr 11.

Reference Type: BACKGROUND

PMID: 23583168 (View on PubMed)

Pepys MB, Hirschfield GM. C-reactive protein: a critical update. J Clin Invest. 2003 Jun;111(12):1805-12. doi: 10.1172/JCI18921. No abstract available.

Reference Type: BACKGROUND

PMID: 12813013 (View on PubMed)

Ganguly P, Alam SF. Role of homocysteine in the development of cardiovascular disease. Nutr J. 2015 Jan 10;14:6. doi: 10.1186/1475-2891-14-6.

Reference Type: BACKGROUND

PMID: 25577237 (View on PubMed)

Kumar A, Palfrey HA, Pathak R, Kadowitz PJ, Gettys TW, Murthy SN. The metabolism and significance of homocysteine in nutrition and health. Nutr Metab (Lond). 2017 Dec 22;14:78. doi: 10.1186/s12986-017-0233-z. eCollection 2017.

Reference Type: BACKGROUND

PMID: 29299040 (View on PubMed)

Mann NJ, Li D, Sinclair AJ, Dudman NP, Guo XW, Elsworth GR, Wilson AK, Kelly FD. The effect of diet on plasma homocysteine concentrations in healthy male subjects. Eur J Clin Nutr. 1999 Nov;53(11):895-9. doi: 10.1038/sj.ejcn.1600874.

Reference Type: BACKGROUND

PMID: 10557004 (View on PubMed)

Gilstrap LG, Wang TJ. Biomarkers and cardiovascular risk assessment for primary prevention: an update. Clin Chem. 2012 Jan;58(1):72-82. doi: 10.1373/clinchem.2011.165712. Epub 2011 Nov 28.

Reference Type: BACKGROUND

PMID: 22125305 (View on PubMed)

Tiu SC, Choi CH, Shek CC, Ng YW, Chan FK, Ng CM, Kong AP. The use of aldosterone-renin ratio as a diagnostic test for primary hyperaldosteronism and its test characteristics under different conditions of blood sampling. J Clin Endocrinol Metab. 2005 Jan;90(1):72-8. doi: 10.1210/jc.2004-1149. Epub 2004 Oct 13.

Reference Type: BACKGROUND

PMID: 15483077 (View on PubMed)

Stock J. Triglycerides and cardiovascular risk: Apolipoprotein B holds the key. Atherosclerosis. 2019 May;284:221-222. doi: 10.1016/j.atherosclerosis.2019.03.004. Epub 2019 Mar 21. No abstract available.

Reference Type: BACKGROUND

PMID: 30914143 (View on PubMed)

Ference BA, Kastelein JJP, Catapano AL. Lipids and Lipoproteins in 2020. JAMA. 2020 Aug 11;324(6):595-596. doi: 10.1001/jama.2020.5685. No abstract available.

Reference Type: BACKGROUND

PMID: 32717042 (View on PubMed)

Tipton KD, Hamilton DL, Gallagher IJ. Assessing the Role of Muscle Protein Breakdown in Response to Nutrition and Exercise in Humans. Sports Med. 2018 Mar;48(Suppl 1):53-64. doi: 10.1007/s40279-017-0845-5.

Reference Type: BACKGROUND

PMID: 29368185 (View on PubMed)

Kochlik B, Gerbracht C, Grune T, Weber D. The Influence of Dietary Habits and Meat Consumption on Plasma 3-Methylhistidine-A Potential Marker for Muscle Protein Turnover. Mol Nutr Food Res. 2018 May;62(9):e1701062. doi: 10.1002/mnfr.201701062. Epub 2018 Apr 19.

Reference Type: BACKGROUND

PMID: 29573154 (View on PubMed)

Peters NC, Contento IR, Kronenberg F, Coleton M. Adherence in a 1-year whole foods eating pattern intervention with healthy postmenopausal women. Public Health Nutr. 2014 Dec;17(12):2806-15. doi: 10.1017/S1368980014000044.

Reference Type: BACKGROUND

PMID: 24499772 (View on PubMed)

Sotos-Prieto M, Bhupathiraju SN, Mattei J, Fung TT, Li Y, Pan A, Willett WC, Rimm EB, Hu FB. Association of Changes in Diet Quality with Total and Cause-Specific Mortality. N Engl J Med. 2017 Jul 13;377(2):143-153. doi: 10.1056/NEJMoa1613502.

Reference Type: BACKGROUND

PMID: 28700845 (View on PubMed)

Milosevic I, Levy HC, Alcolado GM, Radomsky AS. The Treatment Acceptability/Adherence Scale: Moving Beyond the Assessment of Treatment Effectiveness. Cogn Behav Ther. 2015;44(6):456-69. doi: 10.1080/16506073.2015.1053407. Epub 2015 Jun 19.

Reference Type: BACKGROUND

PMID: 26091250 (View on PubMed)

Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.

Reference Type: BACKGROUND

PMID: 8532986 (View on PubMed)

van der Wardt V, Harrison JK, Welsh T, Conroy S, Gladman J. Withdrawal of antihypertensive medication: a systematic review. J Hypertens. 2017 Sep;35(9):1742-1749. doi: 10.1097/HJH.0000000000001405.

Reference Type: BACKGROUND

PMID: 28486271 (View on PubMed)

Zeiler E, Gabriel S, Ncube M, Thompson N, Newmire D, Scharf EL, Goldhamer AC, Myers TR. Prolonged Water-Only Fasting Followed by a Whole-Plant-Food Diet Is a Potential Long-Term Management Strategy for Hypertension and Obesity. Nutrients. 2024 Nov 20;16(22):3959. doi: 10.3390/nu16223959.

Reference Type: DERIVED

PMID: 39599745 (View on PubMed)

Other Identifiers

TNHF2020-1HTN

Identifier Type: -

Identifier Source: org_study_id