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This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Water-only Fasting Group | Experimental | Participants who voluntarily elect and are approved to water-only fast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-only Fasting | Other | Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 10-60 days after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe mean changes in resting blood pressure from baseline | Changes in SBP and diastolic blood pressure will be measured using a digital blood pressure device and reported as mmHg | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Toshia R Myers, PhD | Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TrueNorth Health Center | Santa Rosa | California | 95404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30700139 | Background | 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. | |
| 24881994 |
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After publication, the IPD will be available by contacting the corresponding author.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D005215 | Fasting |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| 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 | Up to 7-40 days after baseline and 6-weeks after end of refeed |
| 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 | 6-weeks after end of refeed |
| 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 | 6-weeks after end of refeed |
| Describe mean changes in lipid profile from baseline |
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 |
| 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 |
| Describe mean changes in fasting glucose and apolipoprotein B from baseline | Changes in fasting glucose and apolipoprotein B will be assessed using serum and reported as mg/dL | 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 |
| Describe mean changes in body mass index (BMI) from baseline | Changes in BMI will be assessed by measuring weight in kilograms (kg) and height in meters (m) and reported as kg/m2 | 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 |
| Describe mean changes in insulin from baseline | Changes in insulin will be assessed by using serum and reported as uIU/ml | 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 |
| Describe mean changes in visceral adipose tissue from baseline | Changes in visceral adipose tissue will be assessed using dual-energy X-ray absorptiometry and presented as grams | Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed |
| Describe mean changes in high sensitivity C-reactive protein (hsCRP) from baseline | Changes in hsCRP will be assessed using serum and reported as mg/L | 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 |
| Describe mean changes in gamma-glutamyl-transferase (GGT) from baseline | Changes in GGT will be assessed using serum and reported as U/L | 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 |
| Describe mean changes in lipoprotein associated phospholipase A2 from baseline | Changes in lipoprotein associated phospholipase A2 will be assessed using serum and reported as nmol/min/mL | 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 |
| Describe mean changes in homocysteine from baseline | Changes in homocysteine will be assessed using serum and reported as umol/L | 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 |
| Describe mean changes in aldosterone from baseline | Changes in aldosterone will be assessed using serum and 24 hour urine and reported as ng/dL | 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 |
| Describe mean changes in abdominal circumference from baseline | Abdominal circumference will be measured at minimal waist and reported in centimeters | 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 |
| Describe changes in renin activity from baseline | Changes in renin activity will be assessed using serum and reported as ng/mL/hr | 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 |
| Describe changes in sodium from baseline | Changes in sodium will be assessed using 24 hour urine and reported as mmol/24 hr | 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 |
| Describe changes in creatinine and total protein from baseline | Changes in sodium will be assessed using 24 hour urine and reported as mg/dL | 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 |
| Describe changes in potassium from baseline | Changes in potassium will be assessed using 24 hour urine and reported as mmol/L | 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 |
| Describe changes in albumin from baseline | Changes in albumin will be assessed using 24 hour urine and reported as ug/mL | 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 |
| Describe changes in 3-methyl-histidine from baseline | Changes in 3-methyl-histidine will be assessed using 24 hour urine and reported as umol/day | Baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed |
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