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Interventions and public health nutrition

Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors—the ACOORH trial

European Journal of Clinical Nutrition volume 75, pages 661–669 (2021)Cite this article

Subjects

Abstract

Background

As formula diets have demonstrated to be effective in reducing weight, we hypothesised that in patients with overweight or obesity and accompanied cardiovascular risk factors, combining a liquid formula diet with a lifestyle intervention is superior in reducing weight and improving cardiovascular risk factors than lifestyle intervention alone.

Methods

In this multicenter RCT 463 participants with overweight or obesity (BMI: 27–35 kg/m²; at least one additional co-morbidity of the metabolic syndrome) were randomised (1:2) into either a control group with lifestyle intervention only (CON, n = 155) or a lifestyle intervention group including a liquid meal replacement (INT, n = 308). Both groups used telemonitoring devices (scales and pedometers), received information on healthy diet and were instructed to increase physical activity. Telemonitoring devices automatically transferred data into a personalised online portal and acquired data were discussed. INT obtained a liquid meal replacement substituting three meals/day (~1200 kcal) within the first week. During weeks 2–4, participants replaced two meals/day and during weeks 5–26 only one meal/day was substituted (1300–1500 kcal/day). Follow-up was conducted after 52 weeks. Intention-to-treat analyses were performed. Primary outcome was weight change. Secondary outcomes comprised changes in cardiometabolic risk factors including body composition and laboratory parameters.

Results

From the starting cohort 360 (78%, INT: n = 244; CON: n = 116) and 317 (68%, INT: n = 216; CON: n = 101) participants completed the 26-weeks intervention phase and the 52-weeks follow-up. The estimated treatment difference (ETD) between both groups was −3.2 kg [−4.0; −2.5] (P < 0.001) after 12 weeks and −1.8 kg [−2.8; −0.8] (P < 0.001) after 52 weeks.

Conclusions

A low-intensity lifestyle intervention combined with a liquid meal replacement is superior regarding weight reduction and improvement of cardiovascular risk factors than lifestyle intervention alone.

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Fig. 1: Study flow diagram.
Fig. 2: Mean changes in secondary outcomes.

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Acknowledgements

The ACOORH group thanks their consortium members for their excellent work (a complete list of all consortium members including those who did not met authorship criteria can be seen in the Supplementary information). Furthermore, the authors thank their study staff for their excellent work and Dr. Thomas Keller (ACOMED statistik®, Leipzig, Germany) for his support in the statistical analysis. We would also like to thank Verena Heinicke, Katrin Esefeld, Nina Schaller and Johannes Scherr for their significant support of performing the trial at the local Munich site. The study centre of Freiburg thanks their colleagues Sadaf Koohan and Andrea Stensitzky for their great support by conducting the study. We, the West-German Centre of Diabetes and Health, Düsseldorf, thank our study nurse Bettina Prete for her excellent work.

ACOORH study group

Martin Halle1,2, Nina Schaller1, Martin Röhling3, Kerstin Kempf3, Stephan Martin3,12, Winfried Banzer4, Klaus Michael Braumann5, Jürgen Scholze8, Dagmar Führer-Sakel9, Susanne Tan9, Hans Georg Predel7, Aloys Berg11, Sadaf Koohkan13, David McCarthy6, Hermann Toplak10, Michel Pinget14

Funding

The study was financially supported by the Almased-Wellness-GmbH. The funder had no influence on study hypothesis/design, data collection, execution, data analysis, interpretation, manuscript preparation and/or publication decisions.

Author information

Author notes

  1. These authors contributed equally: Martin Halle, Martin Röhling

Authors and Affiliations

  1. Department of Prevention, Rehabilitation and Sports Medicine, Klinikum rechts der Isar, Technical University of Munich (TUM), Munich, Germany

    Martin Halle & Nina Schaller

  2. DZHK (German Centre for Cardiovascular Research), Partner Site Munich Heart Alliance, Munich, Germany

    Martin Halle

  3. West-German Center of Diabetes and Health, Düsseldorf Catholic Hospital Group, Dusseldorf, Germany

    Martin Röhling, Kerstin Kempf & Stephan Martin

  4. Department of Sports Medicine, Institute for Sports and Sport Science, University of Frankfurt, Frankfurt, Germany

    Winfried Banzer

  5. Faculty of Psychology and Human Movement Sciences, Department of Sports and Movement Medicine, University of Hamburg, Hamburg, Germany

    Klaus Michael Braumann

  6. Public Health Nutrition Research Group, London Metropolitan University, London, UK

    David McCarthy

  7. Institute of Cardiovascular Research and Sports Medicine, German Sport University Cologne, Cologne, Germany

    Hans Georg Predel

  8. KARDIOS, Cardiologists in Berlin, Berlin, Germany

    Jürgen Scholze

  9. Department of Endocrinology, Diabetes and Metabolism and Division of Laboratory Research, University Hospital Essen, University Duisburg-Essen, Essen, Germany

    Dagmar Führer-Sakel & Susanne Tan

  10. Department of Medicine, Division of Endocrinology and Diabetology, Medical University of Graz, Graz, Austria

    Hermann Toplak

  11. Faculty of Medicine, University of Freiburg, Freiburg, Germany

    Aloys Berg

  12. Faculty of Medicine, Heinrich Heine University Dusseldorf, Dusseldorf, Germany

    Stephan Martin

  13. University of Freiburg, Institute for Sports and Sports Science, Freiburg, Germany

    Sadaf Koohkan

  14. Department Endocrinologie, Diabete et Maladies Métaboliques, Faculte de Medicine de‘l University de Strasbourg, Strasbourg, France

    Michel Pinget

Authors
  1. Martin Halle
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  2. Martin Röhling
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  5. Kerstin Kempf
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  7. Nina Schaller
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  8. Hans Georg Predel
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  9. Jürgen Scholze
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  10. Dagmar Führer-Sakel
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  11. Hermann Toplak
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  12. Aloys Berg
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Consortia

ACOORH study group

  • Martin Halle
  • , Nina Schaller
  • , Martin Röhling
  • , Kerstin Kempf
  • , Stephan Martin
  • , Winfried Banzer
  • , Klaus Michael Braumann
  • , Jürgen Scholze
  • , Dagmar Führer-Sakel
  • , Susanne Tan
  • , Hans Georg Predel
  • , Aloys Berg
  • , Sadaf Koohkan
  • , David McCarthy
  • , Hermann Toplak
  •  & Michel Pinget

Contributions

AB had the initial idea for the study design and initiated the study. The protocol was designed together with HT and with additional contributions of SM. MH and MR drafted the manuscript. All authors critically revised the manuscript and approved the final version. WB, AB, KMB, DMC, MH, KK, SM, HGP, JS, DF-S and HT collected data at their local sites. A Berg is the guarantor of this work and all co-authors had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Martin Röhling.

Ethics declarations

Conflict of interest

WB, AB, KMB, MH, KK, DMC, HGP, JS, DF-S and HT received research support for their departments from the Almased-Wellness-GmbH to perform the study. AB, MH, DMC and HT have also received speakers' honoraria (category: personal financial interests) from Almased-Wellness-GmbH. All four authors declare that their honoraria had no influence on their contribution to the study design, data collection, data analysis, manuscript preparation and/or publication decisions. NS and MR declare no conflict of interest regarding the publication of this article.

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Consortium representative: Prof. Dr. Aloys Berg (principal investigator). Faculty of Medicine, University of Freiburg, Freiburg, Germany, Breisacher Str. 153, 79110 Freiburg, phone: +49 (0)172-74 14 771, E-mail: aloys.berg@klinikum.uni-freiburg.de.

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Halle, M., Röhling, M., Banzer, W. et al. Meal replacement by formula diet reduces weight more than a lifestyle intervention alone in patients with overweight or obesity and accompanied cardiovascular risk factors—the ACOORH trial. Eur J Clin Nutr 75, 661–669 (2021). https://doi.org/10.1038/s41430-020-00783-4

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  • DOI: https://doi.org/10.1038/s41430-020-00783-4

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