Multi-strain Probiotic Does Not Enhance the Effects of Caloric Restriction on Central Hemodynamic Parameters in Individuals with Hypertension and Overweight

Abstract Arterial stiffness predicts cardiovascular risk, particularly among individuals with hypertension. Recent studies suggest that gut microbiome influences arterial dysfunction. However, there is still a lack of randomized controlled trials (RCTs) evaluating the impact of probiotics on central hemodynamic parameters. The aim of the present study was to evaluate the effects of multi-strain probiotics supplementation on arterial stiffness and central blood pressure in adults with hypertension and excess weight on an energy-restricted diet. A secondary aim was to evaluate the association between changes in body adiposity and central hemodynamic parameters. This double-blind, randomized, placebo-controlled trial included adults (40–65 years) with hypertension and body mass index 25–39.9 kg/m 2 . Participants were assigned to two groups: one group received capsules containing eight probiotic strains (3 × 10 1 ⁰ CFU/day), while the other received placebo capsules. Both groups adhered to caloric restriction. Assessments for both groups were conducted at baseline (W0), week 6 (W6), and week 12 (W12). Initial evaluations included dietary intake, anthropometric measurements, body composition, blood pressure (BP), central hemodynamic parameters (including pulse wave velocity, PWV) and laboratory data. During the baseline visit, all participants were provided with an energy-restricted diet and capsules to be taken over the first six weeks of the study. At W6, anthropometric and BP measurements were repeated, and a new supply of capsules was issued. Comprehensive baseline assessments were performed again at W12. Sixty-six subjects were included in the RCT, 30 completed the study and performed the evaluation of central hemodynamic parameters, being included in the statistical analysis: 13 in the probiotics group and 17 in control group. The intergroup analyses showed no significant effect of probiotics on central hemodynamic parameters. There were positive and significative associations of changes (1) in body weight with modifications in aortic systolic BP, in augmentation pressure and in PWV, and (2) in visceral adipose tissue with modifications in PWV. In conclusion, multi-strain probiotics supplementation, over a 12-week period, did not improve arterial stiffness and other central hemodynamics parameters in individuals presenting hypertension and overweight/obesity following an energy-restricted diet. However, decreases in body adiposity were directly associated with improvement in PWV. The clinical trial was registered at www.ensaiosclinicos.gov.br : RBR-7jw4ry on 01/14/2020.