Prolonged Water-Only Fasting Followed by a Whole-Plant-Food Diet Is a Potential Long-Term Management Strategy for Hypertension and Obesity

Abstract

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 >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.

Keywords: adverse events; anti-hypertensive medication use; hypertension; obesity; prolonged fasting; prolonged water-only fasting; whole-plant-food diet.

Figure 1

Enrollment and participation flow diagram. See “Participant Enrollment and Study Protocol” in the “Materials and Methods” section and “Participant Characteristics” in the “Results” section for details on eligibility and data collection. N, number of participants; BL, baseline; EOF, end-of-fast; EOR, end-of-refeed; 6wFU, six-week follow-up; 12mFU, 12-month follow-up. At EOF visit, 2/29 participants began refeeding before the blood draw and were excluded from serology and urinalysis. At the 6wFU visit, 2 out of 27 provided incomplete data: one provided all data except for anthropometric measurements, and one provided only blood pressure data.

Figure 2

SBP (A,C,E) and DBP (B,D,F) by visit of all participants (A,B) and by baseline medication status (unmedicated (C,D,) and medicated (E,F)). Graphs include individual values as well as first (lower) and third (upper) quartiles and the median value. Circles and squares in panels (C–F) represent unmedicated and medicated SBP/DBP, respectively. Participants who attended the 6wFU visit (n = 27) and 12mFU visit (n = 17) are depicted as unfilled (open) and filled (black) symbols, respectively. Horizontal gray lines represent severity of HTN: SBP 120–129 mmHg, elevated blood pressure; SBP/DBP ≥ 130/80 mmHg, Stage 1 HTN; SBP/DBP ≥ 140/90 mmHg, Stage 2 HTN. A total of 3/29 and 12/29 participants did not provide data at 6wFU and 12mFU visits, respectively. SBP, systolic blood pressure; DBP, diastolic blood pressure; mmHg, millimeter mercury; BL, baseline; EOF, end-of-fast; EOR, end-of-refeed; 6wFU, six-week follow-up; 12mFU, 12-month follow-up; HTN, hypertension.