DOI: 10.5061/dryad.9cnp5hqt8
title: Prolonged water-only fasting followed by a whole-plant-food diet is a potential long-term management strategy for hyper-tension and obesity

description: Objective: This single-arm, pre–post interventional trial
 (clinicaltrials.gov, NCT04515095) investigates the safety, feasibility,
 and potential effectiveness of prolonged water-only fasting followed by a
 whole-plant-food diet in the long-term management of hypertension and
 other cardiometabolic disorders. Methods: Safety was assessed based on
 adverse events (AEs) that were recorded according to Common Terminology
 Criteria for Adverse Events (CTCAE) v5.0. Feasibility was assessed based
 on retention rate, ability to complete minimal fast length, and
 intervention acceptability. Twenty-nine participants with stage 1 and 2
 hypertension and without type 2 diabetes were enrolled from a residential
 fasting center. Results: Study retention was 100% at the end of the refeed
 and 93% at the six-week follow-up visit. Median (range) fasting and
 refeeding duration were 11 (7–40) and 5 (3–17) days, respectively, and 90%
 of participants were able to complete at least 7 days of fasting. The
 majority of AEs were mild (grade 1) and transient and there were no
 higher-grade or serious AEs. At the end of the intervention, median
 systolic/diastolic blood pressure had normalized to below 130/80 mmHg,
 body weight reduced by &gt;5%, and anti-hypertensive medication was
 completely discontinued. These results were sustained for at least six
 weeks and potentially up to one year. Conclusions: Our data suggest that
 the intervention may be a feasible, well-tolerated, low-risk option for
 lowering and managing high blood pressure, excess body weight, and other
 cardiometabolic disorders in people with stage 1 and 2 hypertension.
description: # Prolonged Water-Only Fasting Followed by a Whole-Plant-Food Diet Is a
 Potential Long-Term Management Strategy for Hypertension and Obesity This
 file provides data documentation for the prolonged water-only fasting
 followed by a whole-plant food diet is a potential long-term management
 strategy for hyptension and obesity project. Contact Dr. Toshia Myers
 ([DrMyers@truenorthhealth.org](mailto:DrMyers@truenorthhealth.org)) with
 any questions. This manuscript was published on 11/20/2024: Zeiler, E.,
 Gabriel, S., Ncube, M., Thompson, N., Newmire, D., Scharf, E. L.,
 Goldhamer, A. C., & Myers, T. R. (2024). Prolonged Water-Only Fasting
 Followed by a Whole-Plant-Food Diet Is a Potential Long-Term Management
 Strategy for Hypertension and Obesity. Nutrients, 16(22), 3959\.
 [https://doi.org/10.3390/nu16223959](https://doi.org/10.3390/nu16223959)
 The tnhtn12m_single_tab_minimal_data.csv data file is the minimal dataset
 needed to reproduce manuscript findings. NA: Not applicable ##
 tnhtn12m\_single\_tab\_minimal\_data.csv | variables | units | description
 | | :------------------------ | :--------------: |
 :------------------------------------------------------------------------------------------------------------------------------------------ | | | integer | Row identifier | | ID | integer | Unique participant identifier | | Visit | categorical | Data collection time point | | Height | cm | Height | | Weight | kg | Weight | | BMI | $kg/m^{2}$ | Body mass index | | SBP | mmHg | Systolic blood pressure | | DBP | mmHg | Diastolic blood pressure | | AC | cm | Abdominal circumference | | HTNI | categorical | Baseline hypertension indicator: Yes, hypertensive; No, not hypertensive | | BMICat | categorical | Baseline body mass index category: Norm, normal weight; Over, overweight; Obese, obese | | Total\_Cholesterol | mmol/L | Total Cholesterol | | Triglycerides | mmol/L | Triglycerides | | HDL | mmol/L | High-density lipoprotein | | VLDL | mmol/L | Very-low-density lipoprotein | | LDL | mmol/L | Low-density lipoprotein | | hsCRP | mg/L | High-sensitivity C-reactive protein | | GGT | nmol/(s\*L) | gamma-glutamyl transferase | | Insulin | pmol/L | Insulin | | HOMAIR | real (no units) | Homeostatic model assessment for insulin resistance | | FLI | real (no units) | Fatty Liver Index | | ln\_Insulin | pmol/L | Natural logarithm transformation of Insulin variable. | | ln\_HOMAIR | unitless real | Natural logarithm transformation of HOMAIR variable. | | ln\_GGT | nmol/(s\*L) | Natural logarithm transformation of GGT variable. | | ln\_hsCRP | mg/L | Natural logarithm transformation of hsCRP variable. | | Age | years | Age | | Sex | categorical | Participant’s sex. Options: Male; Female | | Diet | categorical | Self-reported diet. Options: Mixed animal and plant foods; Vegan; SOS-free; Standard American Diet; Vegetarian | | Fasting | days | Number of days that patient spent fasting | | Refeeding | days | Number of days that patient spent refeeding | | FU6W | days | Number of days between departure from fasting center and 6-week follow-up data collection | | FU12M | days | Number of days between 6-week follow-up and 12-month follow-up data collection | | Treatment | categorical | Description of treatment (see Treatment Description table for more information) | | WBC | $\*10^{3}/µL$ | White blood count | | RBC | $\*10^{3}/µL$ | Red blood cell | | Hemoglobin | g/dL | Hemoglobin | | Hematocrit | % | Hematocrit | | MCV | fL | Mean corpuscular volume | | MCH | pg | Mean corpuscular hemoglobin | | MCHC | g/dL | Mean corpuscular hemoglobin concentration | | RDW | % | Red cell distribution width | | Platelets | $\*10^{3}/µL$ | Platelets | | Neutrophils | % | Neutrophils | | Lymphs | % | Lymphocytes | | Monocytes | % | Monocytes | | EOS | % | Eosinophils | | Basos | % | Basophils | | Neutrophils\_Abs | $\*10^{3}/µL$ | Neutrophils | | Lymphs\_Abs | $\*10^{3}/µL$ | Lymphocytes | | Monocytes\_Abs | $\*10^{3}/µL$ | Monocytes | | EOS\_Abs | $\*10^{3}/µL$ | Eosinophils | | Baso\_Abs | $\*10^{3}/µL$ | Basophils | | Immature\_Granulocytes | % | Immature granulocytes | | Immature\_Grans\_Abs | $\*10^{3}/µL$ | Immature granulocytes | | BUN | mg/dL | Blood urea nitrogen | | Creatinine | mg/dL | Creatinine | | eGFR | mL/min/1.73 | Estimated glomerular filtration rate | | BUN.Creatinine\_Ratio | No units (ratio) | BUN/Creatinine Ratio | | Sodium | mmol/L | Sodium | | Potassium | mmol/L | Potassium | | Chloride | mmol/L | Chloride | | Carbon\_Dioxide\_Tot | mmol/L | Carbon Dioxide | | Calcium | mmol/L | Calcium | | Protein\_Tot | g/dL | Protein | | Albumin | g/L | Albumin | | Globulin\_Tot | g/dL | Globulin | | A.G\_Ratio | No units (ratio) | Ratio of Albumin (in g/dL) to Globulin (in g/dL) | | Bilirubin\_Tot | µmol/L | Bilirubin | | Alkaline\_Phosphatase | IU/L | Alkaline Phosphate | | AST\_SGOT | IU/L | Aspartate aminotransferase | | ALT\_SGPT | IU/L | Alanine aminotransferase | | LpPla2 | nmol/min/mL | Lipoprotein-associated phospholipase A2 | | Homocysteine | µmol/L | Homocysteine | | ApoB | mg/dL | Apolipoprotein B | | Renin | ng/mL/hr | Renin Activity, Plasma | | Aldosterone\_Serum | ng/dL | Aldosterone, Serum | | Aldosterone\_Urine | µg/L | Aldosterone, Urine | | ln\_Renin | ng/mL/hr | Natural log transformation of Renin variable | | ln\_Aldosterone\_Serum | ng/dL | Natural log transformation of Aldosterone\_Serum variable | | ln\_Aldosterone\_Urine | µg/L | Natural log transformation of Aldosterone\_Urine variable | | T.F. | Fahrenheit | Body Temperature in Fahrenheit | | T.C. | Celsius | Body Temperature in Celsius | | P | $min^{-1}$ | Pulse in beats per minute | | PO2 | % | Saturation of peripheral oxygen | | Diet.Status | categorical | Description of diet (see Treatment Description table for more information) | | faq\_Q1 | Likert | Item 1 from FAQ survey. See Figure S2 for description. | | faq\_Q2 | Likert | Item 2 from FAQ survey. See Figure S2 for description. | | faq\_Q3 | Likert | Item 3 from FAQ survey. See Figure S2 for description. | | faq\_Q4 | Likert | Item 4 from FAQ survey. See Figure S2 for description. | | faq\_Q5 | Likert | Item 5 from FAQ survey. See Figure S2 for description. | | faq\_Q6 | Likert | Item 6 from FAQ survey. See Figure S2 for description. | | faq\_Q7 | Likert | Item 7 from FAQ survey. See Figure S2 for description. | | faq\_Q8 | Likert | Item 8 from FAQ survey. See Figure S2 for description. | | faq\_Q9 | Likert | Item 9 from FAQ survey. See Figure S2 for description. | | faq\_Q10 | Likert | Item 10 from FAQ survey. See Figure S2 for description. | | faq\_comp | categorical | Missing data flag for the FAQ survey. Has value ‘0’ if no missing data and ‘2’ if data is missing. | | faq\_tot | numeric | Total score on FAQ survey. Sum of items 1 through 10 after reversing polarity of items 4 and 8. | | vegetable | categorical | SOS-code for vegetables (see SOS-code descriptions in table below) | | fruit | categorical | SOS-code for fruits (see SOS-code descriptions in table below) | | avocado | categorical | SOS-code for avocados (see SOS-code descriptions in table below) | | int\_whole\_grain | categorical | SOS-code for whole grains (see SOS-code descriptions in table below) | | prod\_whole\_grain | categorical | SOS-code for grain flours (see SOS-code descriptions in table below) | | refined\_grain | categorical | SOS-code for refined grains (see SOS-code descriptions in table below) | | bean | categorical | SOS-code for legumes (see SOS-code descriptions in table below) | | nut\_seed | categorical | SOS-code for nuts and seeds (see SOS-code descriptions in table below) | | red\_meat | categorical | SOS-code for red meats (see SOS-code descriptions in table below) | | poultry | categorical | SOS-code for poultry (see SOS-code descriptions in table below) | | fish | categorical | SOS-code for fish (see SOS-code descriptions in table below) | | dairy | categorical | SOS-code for dairy (see SOS-code descriptions in table below) | | egg | categorical | SOS-code for eggs (see SOS-code descriptions in table below) | | prep\_salt | categorical | SOS-code for prepared food with salt (see SOS-code descriptions in table below) | | add\_salt | categorical | SOS-code for added salt (see SOS-code descriptions in table below) | | cook\_salt | categorical | SOS-code for food cooked with salt (see SOS-code descriptions in table below) | | prep\_oil | categorical | SOS-code for prepared food with oil (see SOS-code descriptions in table below) | | add\_oil | categorical | SOS-code for added oil (see SOS-code descriptions in table below) | | cook\_oil | categorical | SOS-code for cooked food with oil (see SOS-code descriptions in table below) | | prep\_sugar | categorical | SOS-code for prepared food with sugar (see SOS-code descriptions in table below) | | add\_sugar | categorical | SOS-code for added sugar (see SOS-code descriptions in table below) | | cook\_sugar | categorical | SOS-code for cooked food with sugar (see SOS-code descriptions in table below) | | b12 | categorical | SOS-code for vitamin B12 (see SOS-code descriptions in table below) | | alcohol | categorical | SOS-code for alcohol (see SOS-code descriptions in table below) | | caffeine | categorical | SOS-code for caffeine (see SOS-code descriptions in table below) | | tobacco | categorical | SOS-code for tobacco (see SOS-code descriptions in table below) | | Complete? | categorical | Missing data flag for the SOS survey. Has value ‘0’ if no missing data and ‘2’ if data is missing. | | additional\_supps | binary | “Which additional supplements do you take? (choice=None)” (1 if Yes, 0 if No) | | additional\_supps\_2 | binary | “Which additional supplements do you take? (choice=Omega-3 (including flax oil, fish oil, and others))” (1 if Yes, 0 if No) | | additional\_supps\_3 | binary | “Which additional supplements do you take? (choice=Vitamin D (including D2 or D3))” (1 if Yes, 0 if No) | | additional\_supps\_4 | binary | “Which additional supplements do you take? (choice=Iodine)” (1 if Yes, 0 if No) | | additional\_supps\_5 | binary | “Which additional supplements do you take? (choice=Probiotics)” (1 if Yes, 0 if No) | | additional\_supps\_6 | binary | “Which additional supplements do you take? (choice=Other)” (1 if Yes, 0 if No) | | additional\_supps\_7 | open ended | “Specify ‘other’” | | vegetable\_n | servings per day | Daily servings of vegetables | | fruit\_n | servings per day | Daily servings of fruits | | avocado\_n | servings per day | Daily servings of avocados | | int\_whole\_grain\_n | servings per day | Daily servings of whole grains | | prod\_whole\_grain\_n | servings per day | Daily servings of grain flours | | refined\_grain\_n | servings per day | Daily servings of refined grains | | bean\_n | servings per day | Daily servings of legumes | | nut\_seed\_n | servings per day | Daily servings of nuts and seeds | | red\_meat\_n | servings per day | Daily servings of red meats | | poultry\_n | servings per day | Daily servings of poultry | | fish\_n | servings per day | Daily servings of fish | | dairy\_n | servings per day | Daily servings of dairy | | egg\_n | servings per day | Daily servings of eggs | | prep\_salt\_n | servings per day | Daily servings of food prepared with salt | | add\_salt\_n | servings per day | Daily servings of added salt | | cook\_salt\_n | servings per day | Daily servings of food cooked with salt | | prep\_oil\_n | servings per day | Daily servings of food prepared with oil | | add\_oil\_n | servings per day | Daily servings of added oil | | cook\_oil\_n | servings per day | Daily servings of food cooked with oil | | prep\_sugar\_n | servings per day | Daily servings of food prepared with sugar | | add\_sugar\_n | servings per day | Daily servings of added sugar | | cook\_sugar\_n | servings per day | Daily servings of food cooked with sugar | | b12\_n | servings per day | Daily servings of vitamin B12 | | alcohol\_n | servings per day | Daily servings of alcohol | | caffeine\_n | servings per day | Daily servings of caffeine | | tobacco\_n | servings per day | Daily servings of tobacco | | vg\_cond | servings per day | Conditional daily servings of vegetables (5 - vegetable\_n if vegetable\_n &lt;= 5, 0 otherwise) | | fr\_cond | servings per day | Conditional daily servings of fruit (4 - fruit\_n if fruit\_n &lt;= 4, 0 otherwise) | | vb\_cond | servings per day | Conditional daily servings of vitamin B12 (1 - b12\_b if b12\_n &lt;= 1, 0 otherwise) | | en | servings per day | Conditional daily servings of nuts (nut\_seed\_n - 4 if nut\_seed\_n - 4 &gt; 0, 0 otherwise) | | ea | servings per day | Conditional daily servings of avocado (avocado\_n - 1/2 if avocado\_n - 1/2 &gt; 0, 0 otherwise) | | ap | servings per day | Daily servings of animal protein (red\_meat\_n + poultry\_n + fish\_n + dairy\_n + egg\_n) | | whole\_grain\_flour\_cond | servings per day | Conditional daily servings of grain flour (prod\_whole\_grain\_n - 1/3 if prod\_whole\_grain\_n - 1/3 &gt; 0, 0 otherwise) | | gr | servings per day | Daily servings of grain (whole\_grain\_flour\_cond + refined\_grain\_n) | | as | servings per day | Daily servings of additional substances (alcohol\_n + caffeine\_n + tobacco\_n) | | added\_salt | servings per day | Daily servings of combined added salt (add\_salt\_n + cook\_salt\_n) | | added\_oil | servings per day | Daily servings of combined added oil (add\_oil\_n + cook\_oil\_n) | | added\_sugar | servings per day | Daily servings of combined added sugar (add\_sugar\_n + cook\_sugar\_n) | | non\_adherence | real | Non-adherence score \[vg\_cond + fr\_cond + (2-nut\_seed\_n) + vb\_cond + en + ea + ap + added\_salt + added\_oil + added\_sugar + gr + as] | | vegetable\_f | categorical | SOS-category for vegetables (see SOS-category descriptions in table below) | | fruit\_f | categorical | SOS-category for fruits (see SOS-category descriptions in table below) | | avocado\_f | categorical | SOS-category for avocados (see SOS-category descriptions in table below) | | int\_whole\_grain\_f | categorical | SOS-category for whole grains (see SOS-category descriptions in table below) | | prod\_whole\_grain\_f | categorical | SOS-category for grain flours (see SOS-category descriptions in table below) | | refined\_grain\_f | categorical | SOS-category for refined grains (see SOS-category descriptions in table below) | | bean\_f | categorical | SOS-category for beans (see SOS\_category descriptions in table below) | | nut\_seed\_f | categorical | SOS-category for legumes (see SOS\_category descriptions in table below) | | red\_meat\_f | categorical | SOS-category for red meats (see SOS\_category descriptions in table below) | | poultry\_f | categorical | SOS-category for poultry (see SOS\_category descriptions in table below) | | fish\_f | categorical | SOS-category for fish (see SOS\_category descriptions in table below) | | dairy\_f | categorical | SOS-category for dairy (see SOS\_category descriptions in table below) | | egg\_f | categorical | SOS-category for eggs (see SOS\_category descriptions in table below) | | prep\_salt\_f | categorical | SOS-category for prepared food with salt (see SOS\_category descriptions in table below) | | add\_salt\_f | categorical | SOS-category for added salt (see SOS\_category descriptions in table below) | | cook\_salt\_f | categorical | SOS-category for food cooked with salt (see SOS\_category descriptions in table below) | | prep\_oil\_f | categorical | SOS-category for prepared food with oil (see SOS\_category descriptions in table below) | | add\_oil\_f | categorical | SOS-category for added oil (see SOS\_category descriptions in table below) | | cook\_oil\_f | categorical | SOS-category for food cooked with oil (see SOS\_category descriptions in table below) | | prep\_sugar\_f | categorical | SOS-category for prepared food with sugar (see SOS\_category descriptions in table below) | | add\_sugar\_f | categorical | SOS-category for added sugar (see SOS\_category descriptions in table below) | | cook\_sugar\_f | categorical | SOS-category for food cooked with sugar (see SOS\_category descriptions in table below) | | b12\_f | categorical | SOS-category for vitamin B12 (see SOS\_category descriptions in table below) | | alcohol\_f | categorical | SOS-category for alcohol (see SOS\_category descriptions in table below) | | caffeine\_f | categorical | SOS-category for caffeine (see SOS\_category descriptions in table below) | | tobacco\_f | categorical | SOS-category for tobacco (see SOS\_category descriptions in table below) | | NewDiag | categorical | NewDiag: Yes, No. “Have you been diagnosed with any new diseases/conditions in the past 12 months?” | | Adjunct | categorical | Adjunct: Yes, No. “Have there been any adjunct therapies since the last visit?” | | TNHCVisit | categorical | TNHCVisit: Yes, No. “Have you visited TNHC within the past 12 months?” | | TNHCTimes | numeric | Number of times participant TNHC within the past 12 months | | TNHCLen | days | Length of stay for TNHC visit | | TNHCTreat | open-ended | Description of treatment for TNHC visit | | TNHCComp | open-ended | Description of complications or symptoms experienced since departure from TNHC | ## SOS-Free Diet Screener Codes and Categories The SOS-code is a number between 1 and 12 representing how often the participant consumed a serving of the specified food group, ingredient, beverage, or dietary supplement over the previous 30 days. The codes stand for: | SOS-code | SOS-category | | :------- | :------------ | | 1 | 0 per month | | 2 | 1 per month | | 3 | 2-3 per month | | 4 | 1 per week | | 5 | 2 per week | | 6 | 3-4 per week | | 7 | 5-6 per week | | 8 | 1 per day | | 9 | 2 per day | | 10 | 3 per day | | 11 | 4 per day | | 12 | &gt;= 5 per day | ## Treatment Description | Letter | Description | | :----- | :-------------- | | W | Water | | TB | Vegetable broth | | U | Unrestricted | | J | Juice | | T | Total | The codes in the table above were used to describe the participant’s treatment. As an example, U2J1 T18(as W8TB2W8)+9 stands for: unrestricted diet for 2 days (U2) juice 1 day (J1); total treatment is 18 days (T18) consisting of 8 days of water, 2 days of vegetable broth, and 8 days of water (as W8TB2W8); 9 days of refeeding (+9). ## Unit Description | Unit | Description | | :--- | :--------------------- | | kg | kilogram | | g | gram | | mg | milligram | | µg | microgram | | ng | nanogram | | pg | picogram | | m | meter | | cm | centimeter | | mmHg | millimeters of mercury | | mmol | millimole | | µmol | micromole | | nmol | nanomole | | pmol | picomole | | L | liter | | dL | deciliter | | mL | milliliter | | µL | microliter | | fL | femtoliter | | s | second | | min | minute | | hr | hour | | IU | international unit |