Clinical Trials Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Dec 27, 2020; 12(12): 1299-1313
Published online Dec 27, 2020. doi: 10.4254/wjh.v12.i12.1299
Effect of non-alcoholic beer, diet and exercise on endothelial function, nutrition and quality of life in patients with cirrhosis
Ricardo U Macías-Rodríguez, Astrid Ruiz-Margáin, Berenice M Román-Calleja, May E Espin-Nasser, Nayelli C Flores-García, Aldo Torre, Gretel Galicia-Hernández, Silvia L Rios-Torres, Gabriela Fernández-del-Rivero, Arturo Orea-Tejeda, Oscar A Lozano-Cruz
Ricardo U Macías-Rodríguez, Astrid Ruiz-Margáin, Berenice M Román-Calleja, May E Espin-Nasser, Nayelli C Flores-García, Aldo Torre, Gretel Galicia-Hernández, Silvia L Rios-Torres, Gabriela Fernández-del-Rivero, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico
Ricardo U Macías-Rodríguez, Liver Fibrosis and Nutrition Lab (LFN-Lab), MICTLÁN Network: Mechanisms of Liver Injury, Cell Death and Translational Nutrition in Liver Diseases-Research Network, Mexico City 14080, Mexico
Arturo Orea-Tejeda, Department of Cardiology, Instituto Nacional de Enfermedades Respiratorias, Mexico City 14080, Mexico
Oscar A Lozano-Cruz, Department of Internal Medicine, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City 14080, Mexico
Author contributions: Macías-Rodríguez RU provided the conceptualization, funding acquisition, project administration and resources; Ruiz-Margáin A, Román-Calleja BM, Espin-Nasser ME, Flores-Garcia NC, Galicia-Hernández G, Fernández-del-Rivero G, Orea-Tejeda A and Lozano-Cruz O completed data curation; Macías-Rodríguez RU, Ruiz-Margáin A and Román-Calleja BM finished the formal analysis; Espin-Nasser ME, Román-Calleja BM, Flores-García NC, Galicia-Hernández G and Ríos-Torres SL completed the investigation; Macías-Rodríguez RU and Ruiz-Margáin A provided methodology; Torre A provided the critical flicker frequency device; Orea-Tejeda A provided endothelial function assessment; Macías-Rodríguez RU, Ruiz-Margáin A, Román-Calleja BM and Flores-Garcia NC completed the supervision; Macías-Rodríguez RU, Ruiz-Margáin A, Román-Calleja BM, Espin-Nasser ME, Flores-García NC, Galicia-Hernández G, Fernández-del-Rivero G and Lozano-Cruz O wrote the original draft; Macías-Rodríguez RU, Ruiz-Margáin A, Galicia-Hernández G and Orea-Tejeda A reviewed and edited the manuscript; all authors have read and agreed to the published version of the manuscript.
Supported by Mexican Beer Council/Research Committee on Beer and Health (Consejo de Investigación sobre Salud y Cerveza A.C.), No. RCBH-2014.
Institutional review board statement: The study protocol was approved by the local Research and Ethics Committee at the institution (No. Ref. 1605).
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov. The registration identification number is NCT04041115.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: This study was supported by a research grant awarded in 2014 to Ricardo U. Macías-Rodríguez. The grant was derived from a call for scientific research from the Mexican Beer Council (MBC) and was evaluated by an independent scientific council (Research Committee on beer and health (RCBH)/ Consejo de Investigación sobre Salud y Cerveza A.C). Neither the MBC nor the members of the Committee (RCBH) had any influence in the design or development of the study, nor participated in the drafting of the manuscript, data analysis or data interpretation which was established a priori with a legally binding contract to ensure the independence of the research. The non-alcoholic beer used in this study does not belong to or is produced by the Mexican Beer Council (MBC). None of the authors have any actual or past relationship with the company producing the non-alcoholic beer.
Data sharing statement: Participant data that underlie the results reported in this article after deidentification (Text, tables, figures, appendices) and other documents (study protocol, statistical analysis plan and analytic code) are available on request from the corresponding author at ricardomacro@yahoo.com.mx.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Ricardo U Macías-Rodríguez, MD, MSc, PhD, Assistant Professor, Department of Gastroenterology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Vasco de Quiroga 15, Col. Belisario Domínguez Sección XVI, Mexico City 14080, Mexico. ricardomacro@yahoo.com.mx
Received: August 13, 2020
Peer-review started: August 13, 2020
First decision: September 12, 2020
Revised: September 29, 2020
Accepted: October 29, 2020
Article in press: October 29, 2020
Published online: December 27, 2020
Processing time: 126 Days and 12.1 Hours
Core Tip

Core Tip: Malnutrition is a frequent complication in patients with cirrhosis and it is associated with adverse outcomes. Diet and physical exercise are strategies that have shown a beneficial effect on nutritional status. On the other hand, non-alcoholic beer has several nutrients including vitamin B, minerals and flavonoids that make it an attractive "functional" supplement for patients with cirrhosis. The present study evaluated the effect of a multifactorial intervention that included diet, exercise and non-alcoholic beer, showing that it is safe and well tolerated. This intervention showed improvement in endothelial function, quality of life and nutritional status including muscle mass.