Clinical Trials Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Mar 7, 2019; 25(9): 1116-1131
Published online Mar 7, 2019. doi: 10.3748/wjg.v25.i9.1116
Comprehensive lifestyle intervention vs soy protein-based meal regimen in non-alcoholic steatohepatitis
Peter Deibert, Adhara Lazaro, Denise Schaffner, Aloys Berg, Daniel Koenig, Wolfgang Kreisel, Manfred W Baumstark, Daniel Steinmann, Martin Buechert, Thomas Lange
Peter Deibert, Adhara Lazaro, Denise Schaffner, Manfred W Baumstark, Faculty of Medicine, Department of Medicine, Institute of Exercise and Occupational Medicine, Medical Center, University of Freiburg, Freiburg D-79106, Germany
Aloys Berg, Daniel Koenig, Department of Nutrition, Institute for Sports and Sports Science, University of Freiburg, Freiburg D-79106, Germany
Wolfgang Kreisel, Faculty of Medicine, Department of Medicine, Division of Gastroenterology, Hepatology, Endocrinology and Infectious Diseases, Medical Center, University of Freiburg, Freiburg D-79106, Germany
Daniel Steinmann, University Hospital of Freiburg, Occupational Medicine, Freiburg 79110, Germany
Martin Buechert, Thomas Lange, Faculty of Medicine, Department of Radiology - Medical Physics, Medical Center, University of Freiburg, Freiburg D-79106, Germany
Author contributions: Deibert P, Berg A and König D designed the study; Schaffner D took care of the patients and collected data; Kreisel W and Steinmann D organized recruiting patients; Buechert M and Lange T performed the MRI body composition analyses and spectroscopies; Baumstark M and Deibert P analyzed data; all authors reviewed and discussed the data; Deibert P and Lazaro A wrote the paper.
Supported by (in part) Almased® Wellness Company, Bienenbuettel, Germany. The planning, organisation, monitoring and analysis of the study were performed independently by the investigators. Aloys Berg received a study grant from Almased® Wellness Company. Thomas Lange received a study grant from Helmholtz Alliance ICEMED.
Institutional review board statement: The study was reviewed and approved by the Ethics Review Board of the University of Freiburg Medical Center.
Clinical trial registration statement: The study is registered in the German Clinical Trials Register (DRKS), which is an approved Primary Register in the WHO network.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: all authors declared no conflict of interest.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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:
Corresponding author: Peter Deibert, MD, Professor, Faculty of Medicine, Department of Medicine, Institute of Exercise and Occupational Medicine, Medical Center, University of Freiburg, Hugstetter Str. 55, Freiburg D-79106, Germany.
Telephone: +49-761-27074540 Fax: +49-761-27074700
Received: October 30, 2018
Peer-review started: November 1, 2018
First decision: December 5, 2018
Revised: February 15, 2019
Accepted: February 15, 2019
Article in press: February 15, 2019
Published online: March 7, 2019

Non-alcoholic steatohepatitis (NASH) has become one of the leading causes of liver disease in the western world. In obese patients weight reduction is recommended. Up to now there are no specific guidelines for weight loss in order to reduce hepatic fat content.


To investigate the effects of a 24-wk guided lifestyle intervention program compared to a meal replacement regimen based on soy protein.


Twenty-six subjects with NASH participated in a randomized single-center study. They were randomly assigned to either meal replacement group (MR-G) with soy-yogurt-honey preparation or to guided lifestyle change group (LC-G) with endurance activity and nutrition counselling. Serum alanine transaminase (ALT), aspartate transaminase (AST), lipid parameters, and adipokines were measured. Liver fat content and lipid composition were determined by magnetic resonance imaging and magnetic resonance spectroscopy. Body fat mass and lean body mass were assessed using Bod Pod® device. Pre- and post-intervention monitoring of parameters was performed. Statistical analyses were conducted with SPSS software, results were expressed as median (interquartile range).


Twenty-two subjects (MR-G, n = 11 and LC-G, n = 11) completed the study (9 women, 13 men; age 52.1 (15.0) years, body mass index (BMI) 32.3 (3.3) kg/m²). In both groups a significant weight loss was achieved (MR-G: -6.4 (3.6) kg, P < 0.01; LC-G: -9.1 (10.4) kg, P < 0.01). BMI dropped in both groups (MR-G: -2.3 (1.5) kg/m2, P = 0.003; LC-G: -3.0 (3.4) kg/m2, P = 0.006). Internal fat and hepatic lipid content were markedly reduced in both groups in comparable amount. There was a strong correlation between reduction in liver fat and decrease in ALT. Likewise, both groups showed an improvement in glycemic control and lipid profile. Changes in adipokines, particularly in adiponectin and leptin were closely related to intrahepatic lipid changes.


Comprehensive lifestyle intervention and meal replacement regimen have comparable effects on body and liver fat, as well as decrease in markers of hepatic inflammation among NASH patients.

Keywords: Non-alcoholic steatohepatitis, Meal replacement therapy, Soy protein, Lifestyle change, Weight reduction, Obesity

Core tip: Non-alcoholic steatohepatitis (NASH) is a major cause of chronic liver disease. In obese patients weight reduction is recommended. We studied the effect of a soy protein-based meal replacement therapy and a therapeutic lifestyle intervention in a randomized controlled study of obese patients with NASH. Both groups significantly lost body fat and liver fat while muscle mass remained stable. Corresponding changes were found in blood lipids and adipokines. However, liver fat quality as mean chain length and saturation of lipids was modified differently by each intervention. The relevance of these findings has to be cleared by further studies.