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Original research
Fat-rich versus carbohydrate-rich nutrition in ALS: a randomised controlled study
  1. Johannes Dorst1,
  2. Judith Doenz1,
  3. Katharina Kandler1,
  4. Jens Dreyhaupt2,
  5. Hayrettin Tumani1,
  6. Simon Witzel1,
  7. Joachim Schuster1,3,
  8. Albert C Ludolph1,3
  1. 1 Department of Neurology, University of Ulm, Ulm, Baden-Württemberg, Germany
  2. 2 Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Baden-Württemberg, Germany
  3. 3 German Center for Neurodegenerative Diseases (DZNE), Ulm Site, Ulm, Baden-Württemberg, Germany
  1. Correspondence to Dr Johannes Dorst, Neurology, University of Ulm, Ulm, Germany; Dorst_2001{at}yahoo.de

Abstract

Objective There is growing evidence that the course of amyotrophic lateral sclerosis (ALS) may be influenced beneficially by applying high-caloric food supplements (HCSs). However, it is unknown which composition of nutrients offers optimal tolerability and weight gain.

Methods We conducted a randomised controlled study (Safety and Tolerability of Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS); TOLCAL-ALS study) in 64 patients with possible, probable or definite ALS according to El Escorial criteria. Patients were randomised into four groups: a high-caloric fatty supplement (HCFS; 405 kcal/day, 100% fat), an ultra-high-caloric fatty supplement (UHCFS; 810 kcal/day, 100% fat), an ultra-high-caloric, carbohydrate-rich supplement (UHCCS; 900 kcal/day, 49% carbohydrates) and an open control (OC) group without any supplement. The primary endpoint was tolerability. Patients were followed up over 4 weeks.

Results Gastrointestinal side effects were most frequent in the UHCFS group (75.0%), while loss of appetite was most frequent in the UHCCS group (35.3%). During intervention, patients gained +0.9 kg/month of body weight (IQR −0.9 to 1.5; p=0.03) in the HCFS group and +0.9 kg/month (IQR −0.8 to 2.0; p=0.05) in the UHCFS group. A non-significant trend for weight gain (+0.6 kg/month (IQR −0.3 to 1.9; p=0.08)) was observed in the UHCCS group. Patients in OC group continued to lose body weight (−0.5 kg/month, IQR −1.4 to 1.3; p=0.42).

Interpretation The findings suggest that HCSs frequently cause mild to moderate tolerability issues in patients with ALS, most notably gastrointestinal symptoms in high-fat supplements, and loss of appetite in high-carbohydrate supplements. All three HCSs tested are suited to increase body weight.

  • motor neuron disease
  • randomised trials

Data availability statement

Data are available upon reasonable request. Individual participant data that underlie the results reported in this article, after de-identification (text, tables and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.

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Data availability statement

Data are available upon reasonable request. Individual participant data that underlie the results reported in this article, after de-identification (text, tables and figures), as well as the study protocol will be available. Data will be available beginning 3 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared for analyses to achieve the aims in the approved proposal. Proposals should be directed to johannes.dorst@uni-ulm.de; to gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at https://www.uniklinik-ulm.de/neurologie.html.

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Footnotes

  • Contributors JDor is responsible for the overall content as the guarantor. JDor, JDoe, JDr, JS, HT and ACL conceived of and designed the study. JDor, JDoe, KBK and SW were study investigators. All authors analysed and interpreted data. All authors critically revised the manuscript.

  • Funding This study was an investigator-initiated trial of Ulm University, with institutional support from Nutricia GmbH (Frankfurt a.M., Germany). Nutricia GmbH provided the dietary supplements for this study free of cost.

  • Competing interests JDor reports that the dietary supplements for this study were provided by Nutricia GmbH (Frankfurt a.M., Germany) free of cost. All other authors declare no competing interests related to the content of the manuscript.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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