Evidence map›Paper›PMID 35790976›Full record

ArticleTrials2022

The effects of polyunsaturated fatty acid (PUFA) administration on the microbiome-gut-brain axis in adolescents with anorexia nervosa (the MiGBAN study): study protocol for a longitudinal, double-blind, randomized, placebo-controlled trial.

Lara Keller, Astrid Dempfle, Brigitte Dahmen, Samira Schreiber, Roger A H Adan, Nadia Andrea Andreani, Unna N Danner, Albrecht Eisert, Sergueï Fetissov, Florian Ph S Fischmeister and 10 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Underneath the Gut-Brain Axis in IBD-Evidence of the Non-Obvious.International journal of molecular sciences · 2024
    Review
  9. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 10 institutions in 4 countries.

Lara KellerDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany. lkeller@ukaachen.de.ORCID http://orcid.org/0000-0002-9714-067X
Astrid DempfleInstitute of Medical Informatics and Statistics, Kiel University, Kiel, Germany.
Brigitte DahmenDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
Samira SchreiberDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
Roger A H AdanBrain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.
Nadia Andrea AndreaniMax Planck Institute for Evolutionary Biology, Plön, Germany.
Unna N DannerAltrecht Eating Disorders Rintveld, Altrecht Mental Health Institute, Zeist, The Netherlands.
Albrecht EisertInstitute of Clinical Pharmacology, University Hospital RWTH Aachen, Aachen, Germany.
Sergueï FetissovINSERM UMR-1239, University of Rouen Normandy, Rouen, France.
Florian Ph S FischmeisterInstitute of Psychology, University of Graz, Graz, Austria.
Andreas KarwautzEating Disorders Unit at the Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.
Kerstin KonradSection for Neuropsychology, Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
Karlijn L KooijBrain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.
Stefanie TrinhInstitute of Neuroanatomy, University Hospital RWTH Aachen, Aachen, Germany.
Benny van der VijghAltrecht Eating Disorders Rintveld, Altrecht Mental Health Institute, Zeist, The Netherlands.
Annemarie A van ElburgAltrecht Eating Disorders Rintveld, Altrecht Mental Health Institute, Zeist, The Netherlands.
Michael ZeilerEating Disorders Unit at the Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.
John BainesMax Planck Institute for Evolutionary Biology, Plön, Germany.
Jochen Seitz *Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
Beate Herpertz-Dahlmann *Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital RWTH Aachen, Aachen, Germany.
RWTH Aachen University · DEChristian-Albrechts-Universität zu Kiel · DEMedical University of Vienna · ATUniversity Medical Center Utrecht · NLUtrecht University · NLAltrecht GGZ · NLInserm · FRMax Planck Institute for Evolutionary Biology · DEUniversitätsklinikum Aachen · DEUniversity of Graz · AT

Funding

Bundesministerium für Bildung und Forschung ERA-NET NEURON 01EW1906A
6 · The paper itself

Abstract

backgroundAnorexia 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.

methodsThis 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 registrationGerman Clinical Trials Register DRKS00017130 . Registered on 12 November 2019.

Indexed as

Anorexia NervosaMicrobiotaAdolescentBrain-Gut AxisFatty Acids, UnsaturatedHumansQuality of LifeRandomized Controlled Trials as TopicFatty Acids, UnsaturatedAnorexia nervosaClinical studyGut microbiomeGut microbiotaGut permeabilityInflammationMicrobiome-gut-brain axisPolyunsaturated fatty acidsRCTSupplementation

Identifiers

PMID35790976
PMCPMC9254435
OpenAlexW4283805081

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.