Abstract
Background: Anorexia nervosa (AN) is a severe psychiatric disease that often takes a chronic course due to insufficient treatment options. Emerging evidence on the gut-brain axis offers the opportunity to find innovative treatments for patients with psychiatric disorders. The gut microbiome of patients with AN shows profound alterations that do not completely disappear after weight rehabilitation. In previous studies, the administration of polyunsaturated fatty acids (PUFA) resulted in effects that might be beneficial in the treatment of AN, affecting the microbiome, body weight and executive functions. Therefore, the MiGBAN study aims to examine the effects of a nutritional supplementation with PUFA on the gut microbiome and body mass index (BMI) in patients with AN.
Methods: This is a longitudinal, double-blind, randomized, placebo-controlled trial. Within 2 years, 60 adolescent patients aged 12 to 19 years with AN will receive either PUFA or placebo for 6 months additional to treatment as usual. After 1 year, the long-term effect of PUFA on the gut microbiome and consecutively on BMI will be determined. Secondary outcomes include improvement of gastrointestinal symptoms, eating disorder psychopathology, and comorbidities. Additionally, the interaction of the gut microbiome with the brain (microbiome-gut-brain axis) will be studied by conducting MRI measurements to assess functional and morphological changes and neuropsychological assessments to describe cognitive functioning. Anti-inflammatory effects of PUFA in AN will be examined via serum inflammation and gut permeability markers. Our hypothesis is that PUFA administration will have positive effects on the gut microbiota and thus the treatment of AN by leading to a faster weight gain and a reduction of gastrointestinal problems and eating disorder psychopathology.
Discussion: Due to previously heterogeneous results, a systematic and longitudinal investigation of the microbiome-gut-brain axis in AN is essential. The current trial aims to further analyse this promising research field to identify new, effective therapeutic tools that could help improve the treatment and quality of life of patients. If this trial is successful and PUFA supplementation contributes to beneficial microbiome changes and a better treatment outcome, their administration would be a readily applicable additional component of multimodal AN treatment. Trial registration: German Clinical Trials Register DRKS00017130. Registered on 12 November 2019.
| Original language | English |
|---|---|
| Article number | 545 |
| Pages (from-to) | 1-15 |
| Journal | Trials |
| Volume | 23 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 5 Jul 2022 |
Bibliographical note
Funding Information:Open Access funding enabled and organized by Projekt DEAL. The trial is funded by the German Ministry for Education and Research (BMBF) within the framework of a research network funded by the EU (European Research Association (ERA)-NET NEURON). The funding of the BMBF had no role in the design of the study and will not have an impact on further stages of the trial, including collection, analysis and interpretation of data and the publication process.
Funding Information:
The trial is being performed within the framework of the EU-funded, international ERA-NET NEURON consortium investigating the microbiome-gut-brain axis in AN (MiGBAN, ERA-NET NEURON 2019-2021, Nr. 103), funded by the German Ministry for Research and Education (BMBF). We acknowledge the collaboration with our partners in The Netherlands, Austria and France. Moreover, we appreciate the cooperation and support of the CTC-A in conducting and monitoring the study and want to thank all participants and their legal guardians.
Funding Information:
The trial is being performed within the framework of the EU-funded, international ERA-NET NEURON consortium investigating the microbiome-gut-brain axis in AN (MiGBAN, ERA-NET NEURON 2019-2021, Nr. 103), funded by the German Ministry for Research and Education (BMBF). We acknowledge the collaboration with our partners in The Netherlands, Austria and France. Moreover, we appreciate the cooperation and support of the CTC-A in conducting and monitoring the study and want to thank all participants and their legal guardians.
Publisher Copyright:
© 2022, The Author(s).
Funding
Open Access funding enabled and organized by Projekt DEAL. The trial is funded by the German Ministry for Education and Research (BMBF) within the framework of a research network funded by the EU (European Research Association (ERA)-NET NEURON). The funding of the BMBF had no role in the design of the study and will not have an impact on further stages of the trial, including collection, analysis and interpretation of data and the publication process. The trial is being performed within the framework of the EU-funded, international ERA-NET NEURON consortium investigating the microbiome-gut-brain axis in AN (MiGBAN, ERA-NET NEURON 2019-2021, Nr. 103), funded by the German Ministry for Research and Education (BMBF). We acknowledge the collaboration with our partners in The Netherlands, Austria and France. Moreover, we appreciate the cooperation and support of the CTC-A in conducting and monitoring the study and want to thank all participants and their legal guardians. The trial is being performed within the framework of the EU-funded, international ERA-NET NEURON consortium investigating the microbiome-gut-brain axis in AN (MiGBAN, ERA-NET NEURON 2019-2021, Nr. 103), funded by the German Ministry for Research and Education (BMBF). We acknowledge the collaboration with our partners in The Netherlands, Austria and France. Moreover, we appreciate the cooperation and support of the CTC-A in conducting and monitoring the study and want to thank all participants and their legal guardians.
Keywords
- Anorexia nervosa
- Clinical study
- Gut microbiome
- Gut microbiota
- Gut permeability
- Inflammation
- Microbiome-gut-brain axis
- Polyunsaturated fatty acids
- RCT
- Supplementation