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HypertensionNCT04515095

Water-only Fasting in the Treatment of Hypertension Patients

A study testing Water-only Fasting in people with Hypertension, run by TrueNorth Health Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Water-only Fasting
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
16 Aug 2020to 1 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • TrueNorth Health Center

    Santa Rosa, California, 95404

Other trials in United States

About this study

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

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

Read the 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
Being tested
Water-only Fasting
Keywords
fasting, water-only fasting, whole-plant-food diet
Medical subject headings
Hypertension, Fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Water-only FastingOther

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

Study groups in NCT04515095
Study groupRoleWhat they receive
Water-only Fasting GroupExperimentalParticipants who voluntarily elect and are approved to water-only fast.
Receives: Other: Water-only Fasting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 10-60 days after baseline

Secondary outcomes (4)

  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)

    SBP will be measured using digital blood pressure device and reported in mmHg

    Measured: 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

  2. 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

    Measured: Up to 7-40 days after baseline and 6-weeks after end of refeed

  3. 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

    Measured: 6-weeks after end of refeed

  4. 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

    Measured: 6-weeks after end of refeed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2020
  2. Study start16 Aug 2020
  3. Primary completion29 Sep 2021
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04515095
Sponsor's protocol ID
TNHF2020-1HTN
Status last verified
Nov 2023
First submitted
12 Aug 2020
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication, the IPD will be available by contacting the corresponding author.

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. No abstract available.

    PubMed 30700139

  • 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.

    PubMed 24881994

  • 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.

    PubMed 12493255

  • 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.

    PubMed 29146535

  • 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.

    PubMed 16755308

  • 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.

    PubMed 10706323

  • 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.

    PubMed 25399269

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

    PubMed 15053002

  • 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.

    PubMed 28097354

  • 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.

    PubMed 26551272

  • 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.

    PubMed 29848493

  • 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.

    PubMed 21262990

  • 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.

    PubMed 30806496

  • 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.

    PubMed 26702078

  • 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.

    PubMed 30077215

Questions about this trial

What is this clinical trial studying?

A study testing Water-only Fasting in people with Hypertension, run by TrueNorth Health Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04515095, which also lists 48 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.

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