Ignite Creation Date:
2025-12-24 @ 1:56 PM
Ignite Modification Date:
2026-01-01 @ 8:10 PM
Study NCT ID:
NCT04515095
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2020-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Water-only Fasting in the Treatment of Hypertension Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2020-08-12', 'studyFirstSubmitQcDate': '2020-08-14', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Describe mean changes in resting blood pressure from baseline', 'timeFrame': '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', 'description': 'Changes in SBP and diastolic blood pressure will be measured using a digital blood pressure device and reported as mmHg'}, {'measure': 'Describe mean changes in lipid profile from baseline', 'timeFrame': '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', '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'}, {'measure': 'Describe mean changes in fasting glucose and apolipoprotein B from baseline', 'timeFrame': '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', 'description': 'Changes in fasting glucose and apolipoprotein B will be assessed using serum and reported as mg/dL'}, {'measure': 'Describe mean changes in body mass index (BMI) from baseline', 'timeFrame': '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', 'description': 'Changes in BMI will be assessed by measuring weight in kilograms (kg) and height in meters (m) and reported as kg/m2'}, {'measure': 'Describe mean changes in insulin from baseline', 'timeFrame': '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', 'description': 'Changes in insulin will be assessed by using serum and reported as uIU/ml'}, {'measure': 'Describe mean changes in visceral adipose tissue from baseline', 'timeFrame': 'Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed', 'description': 'Changes in visceral adipose tissue will be assessed using dual-energy X-ray absorptiometry and presented as grams'}, {'measure': 'Describe mean changes in high sensitivity C-reactive protein (hsCRP) from baseline', 'timeFrame': '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', 'description': 'Changes in hsCRP will be assessed using serum and reported as mg/L'}, {'measure': 'Describe mean changes in gamma-glutamyl-transferase (GGT) from baseline', 'timeFrame': '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', 'description': 'Changes in GGT will be assessed using serum and reported as U/L'}, {'measure': 'Describe mean changes in lipoprotein associated phospholipase A2 from baseline', 'timeFrame': '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', 'description': 'Changes in lipoprotein associated phospholipase A2 will be assessed using serum and reported as nmol/min/mL'}, {'measure': 'Describe mean changes in homocysteine from baseline', 'timeFrame': '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', 'description': 'Changes in homocysteine will be assessed using serum and reported as umol/L'}, {'measure': 'Describe mean changes in aldosterone from baseline', 'timeFrame': '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', 'description': 'Changes in aldosterone will be assessed using serum and 24 hour urine and reported as ng/dL'}, {'measure': 'Describe mean changes in abdominal circumference from baseline', 'timeFrame': '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', 'description': 'Abdominal circumference will be measured at minimal waist and reported in centimeters'}, {'measure': 'Describe changes in renin activity from baseline', 'timeFrame': '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', 'description': 'Changes in renin activity will be assessed using serum and reported as ng/mL/hr'}, {'measure': 'Describe changes in sodium from baseline', 'timeFrame': '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', 'description': 'Changes in sodium will be assessed using 24 hour urine and reported as mmol/24 hr'}, {'measure': 'Describe changes in creatinine and total protein from baseline', 'timeFrame': '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', 'description': 'Changes in sodium will be assessed using 24 hour urine and reported as mg/dL'}, {'measure': 'Describe changes in potassium from baseline', 'timeFrame': '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', 'description': 'Changes in potassium will be assessed using 24 hour urine and reported as mmol/L'}, {'measure': 'Describe changes in albumin from baseline', 'timeFrame': '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', 'description': 'Changes in albumin will be assessed using 24 hour urine and reported as ug/mL'}, {'measure': 'Describe changes in 3-methyl-histidine from baseline', 'timeFrame': 'Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed', 'description': 'Changes in 3-methyl-histidine will be assessed using 24 hour urine and reported as umol/day'}], 'primaryOutcomes': [{'measure': 'Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0', 'timeFrame': 'up to 10-60 days after baseline', 'description': 'Adverse events will be identified through participant interviews and medical record review'}], 'secondaryOutcomes': [{'measure': '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)', 'timeFrame': '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', 'description': 'SBP will be measured using digital blood pressure device and reported in mmHg'}, {'measure': 'Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on treatment acceptability', 'timeFrame': 'Up to 7-40 days after baseline and 6-weeks after end of refeed', 'description': 'Treatment acceptability will be assessed using the validated Treatment Adherence/Acceptability Questionnaire'}, {'measure': 'Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability', 'timeFrame': '6-weeks after end of refeed', 'description': 'Food acceptability will be assed using the validated Food Acceptability Questionnaire'}, {'measure': 'Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece', 'timeFrame': '6-weeks after end of refeed', 'description': 'Dietary adherence rates will be assessed using the SOS-free Dietary Screener'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fasting', 'water-only fasting', 'whole-plant-food diet'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '30700139', 'type': 'BACKGROUND', 'citation': "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 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J Hypertens. 2017 Sep;35(9):1742-1749. doi: 10.1097/HJH.0000000000001405.'}, {'pmid': '39599745', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Any gender\n2. 30-75 years old\n3. Diagnosis of Stage 1 or 2 hypertension\n4. Fasting plasma glucose \\<126mg/dL and/or hemoglobin A1c \\<7 percent\n5. Elect and qualify for a water-only fast of at least 7 consecutive days\n6. Provide informed consent\n7. Internet and computer access\n8. Able to go to LabCorp for 6-week follow-up visit\n9. Willing/able to collect 24-hour urine sample prior to water-only fasting\n\nExclusion Criteria:\n\n1. Systolic Blood Pressure/Diastolic Blood Pressure \\>180/120 mmHg\n2. Active malignancy\n3. Active kidney disease (creatinine over 2.0)\n4. Active inflammatory disorder including classic autoimmune connective tissue (Lupus, Sjogrens, ANCA), multiple sclerosis, and inflammatory bowel disorders (Ulcerative colitis, Crohn's)\n5. Stroke, heart attack, deep vein thrombosis, atrial fibrillation, anticoagulant therapy, or pulmonary embolism within the last 12 months\n6. Inability to discontinue medications or supplements\n7. Abdominal metal implants\n8. Inability to consume only plant food for at least 48 hours before fast begins.\n9. Unable to lay still on the back for at least 10 min."}, 'identificationModule': {'nctId': 'NCT04515095', 'briefTitle': 'Water-only Fasting in the Treatment of Hypertension Patients', 'organization': {'class': 'OTHER', 'fullName': 'TrueNorth Health Foundation'}, 'officialTitle': 'A Safety and Feasibility Study of Water-only Fasting and Refeeding for Treatment of Stage 1 and 2 Hypertensive Patients', 'orgStudyIdInfo': {'id': 'TNHF2020-1HTN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Water-only Fasting Group', 'description': 'Participants who voluntarily elect and are approved to water-only fast.', 'interventionNames': ['Other: Water-only Fasting']}], 'interventions': [{'name': 'Water-only Fasting', 'type': 'OTHER', 'description': 'Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.', 'armGroupLabels': ['Water-only Fasting Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95404', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'TrueNorth Health Center', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}], 'overallOfficials': [{'name': 'Toshia R Myers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After publication, the IPD will be available by contacting the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TrueNorth Health Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Toshia Myers', 'investigatorAffiliation': 'TrueNorth Health Foundation'}}}}