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Rationale and Design of a Randomized Controlled Trial to Evaluate the Effects of Probiotics during Energy Restriction on Blood Pressure, Body Composition, Metabolic Profile and Vascular Function in Obese Hypertensive Individuals

Artery Research volume 26, pages 102–110 (2020)Cite this article

Abstract

Introduction

Hypertension ofen clusters with other cardiovascular risk factors such as obesity, dyslipidemia and glucose intolerance. Weight loss can decrease Blood Pressure (BP) and improve cardiometabolic abnormalities. There is evidence that hypertension and obesity are associated with alterations in gut microbiome. Recent studies evaluating the effects of probiotics on BP, body weight, metabolic profile, inflammatory biomarkers, endothelial function and arterial stiffness found inconsistent results, probably due to the wide heterogeneity in trials design. To date, it is not known if probiotics can potentiate the effects of energy restriction in individuals with increased risk of metabolic, inflammatory and vascular abnormalities such as individuals presenting hypertension and obesity.

Objective

To evaluate the effects of probiotics during energy restriction on BP, body adiposity (total, central and visceral), insulin resistance, lipid profile, microvascular reactivity and arterial stiffness in obese hypertensive subjects.

Methods

This 12-week randomized, double-blind, controlled clinical trial with obese hypertensive adults, instructed to follow an energy-reduced diet (-800 Kcal/day) will be conducted at State University of Rio de Janeiro, Brazil. Probiotics and control groups will take one capsule/day containing nine freeze-dried probiotic strains and cellulose, respectively. At baseline and at the end of the study, participants will undergo nutritional, laboratory, BP and vascular evaluation. Nutritional assessment will include bioelectrical impedance analysis and dual energy X-ray absorptiometry. Laboratory parameters will include glucose, insulin, lipid profile, C-reactive protein, adiponectin, tumor necrosis factor alpha, interleukin-6 and lipopolysaccharide. Post-occlusive microvascular reactivity will be evaluated by laser speckle contrast imaging and oscillometric pulse wave analysis by Mobil-O-Graph.

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Authors and Affiliations

  1. Discipline of Clinical and Experimental Pathophysiology, State University of Rio de Janeiro, Avenida Vinte e Oito de Setembro, 77 - rooms 361 and 363, Vila Isabel, Rio de Janeiro, RJ, Brazil

    Marcella Rodrigues Guedes, Karine Scanci da Silva Pontes & Débora Cristina Torres Valença

  2. Department of Clinical Medicine, State University of Rio de Janeiro, Avenida Vinte e Oito de Setembro, 77, room 329, Vila Isabel, Rio de Janeiro, RJ, Brazil

    Wille Oigman & Mario Fritsch Neves

  3. Department of Applied Nutrition, Nutrition Institute, State University of Rio de Janeiro, Avenida Vinte e Oito de Setembro, 77 - rooms 361 and 363, Vila Isabel, Rio de Janeiro, RJ, Brazil

    Márcia Regina Simas Torres Klein

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  1. Marcella Rodrigues Guedes
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  2. Karine Scanci da Silva Pontes
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Data availability statement: Data sharing is not applicable to this article as no new data were created or analyzed in this study.

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Guedes, M.R., da Silva Pontes, K.S., Valença, D.C.T. et al. Rationale and Design of a Randomized Controlled Trial to Evaluate the Effects of Probiotics during Energy Restriction on Blood Pressure, Body Composition, Metabolic Profile and Vascular Function in Obese Hypertensive Individuals. Artery Res 26, 102–110 (2020). https://doi.org/10.2991/artres.k.200429.001

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Artery Research

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