Abstract
Background
Most people with anorexia nervosa (pAN) have digestive symptoms, which affect tolerance to nutritional treatment. Oligomeric oral nutritional supplements may be better absorbed and tolerated than polymeric ones. Our aim was to compare an oligomeric versus a polymeric nutritional supplement in pAN in terms of worsening of digestive symptoms after ingestion (primary objective) and in terms of sensory perception of the supplement (secondary objective).
Methods
A randomised, crossover, double-blind, controlled clinical trial was conducted. Inclusion criteria were: male or female aged 12–50 years with anorexia nervosa treated at the Eating Disorders Unit of the Hospital Regional Universitario de Málaga, Spain. Participants were randomised to first receive one container of the oligomeric or polymeric supplement. A digestive symptom questionnaire was administered, which they completed again after taking the supplement, together with a questionnaire for sensory evaluation of the supplement. One week later, they received a container of the other type of supplement, and the process was repeated. Analysis was performed on a per protocol basis.
Results
Ten people were randomised to the oligomeric-polymeric sequence and 12 to the polymeric-oligomeric sequence, of whom 9 and 11, respectively, finally received the intervention and were analysed. There were no statistically significant differences in digestive symptoms between the two supplements. The oligomeric one scored lower on taste and higher on acidity. The median (interquartile range) for oligomeric and polymeric were respectively: taste 6.5 (4), 8(3), p 0.03; acidity 0 (1), 0 (0), p 0.01.
Conclusions
In pAN, there is no difference in the worsening of digestive symptoms after ingestion of oligomeric versus polymeric supplements. Polymerics are perceived as having better taste and less acidity.
Trial registration
The trial is registered at ClinicalTrials.gov, number NCT05184738.
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Fig. 1: Participant flow in the study.
Data availability
Data supporting the results of this trial are available from the corresponding author upon reasonable request.
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Acknowledgements
The study was monitored by the METAnetwork. The IBIMA Department of Biostatistics collaborated in the statistical analysis of the study.
Funding
Adventia Pharma partially collaborated with an unconditional grant and the free provision of nutritional supplements. IRG holds a Río Hortega contract from the Carlos III National Health Institute, co-funded by European Social Fund 2014-2020 “The FSE invests in your future”; number: CM20/00225. The researchers declare their independence in the conduct of the study. The funder had no role in the study design, data collection, analysis, interpretation of data, the writing of this article, or the decision to submit it for publication.
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Authors and Affiliations
Servicio de Endocrinología y Nutrición, Hospital Regional Universitario de Málaga, Malaga, Spain
Ignacio Ruiz García, Nuria Porras Pérez, Francisca García Torres, Lourdes Olivas Delgado, Francisco José Sánchez Torralvo & Gabriel Olveira
Instituto de Investigación Biomédica de Málaga y Plataforma en Nanomedicina-IBIMA Plataforma BIONAND, Malaga, Spain
Ignacio Ruiz García, Nuria Porras Pérez, Francisca García Torres, Lourdes Olivas Delgado, Francisco José Sánchez Torralvo & Gabriel Olveira
Facultad de Medicina de la Universidad de Málaga, Departamento de Medicina y Dermatología, Malaga, Spain
Ignacio Ruiz García & Gabriel Olveira
Servicio de Salud Mental, Hospital Regional Universitario de Málaga, Malaga, Spain
Margarita Pascual López & Carmen Fernández Marzalo
CIBER de Diabetes y Enfermedades Metabólicas Asociadas, Instituto de Salud Carlos III, Malaga, Spain
Gabriel Olveira
Authors
Ignacio Ruiz García
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2. Nuria Porras Pérez
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3. Francisca García Torres
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4. Lourdes Olivas Delgado
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5. Francisco José Sánchez Torralvo
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6. Margarita Pascual López
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7. Carmen Fernández Marzalo
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8. Gabriel Olveira
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Contributions
Conceptualization: GO; methodology: IRG, FGT, NPP, GO; software: IRG, NPP, GO; validation: IRG, GO; formal analysis: IRG, NPP, FJST, GO; investigation: IRG, FGT, NPP, CFM, LOD, GO; resources: IRG, FGT, NPP, CFM, LOD, FJST, MPL, GO; data curation: IRG, NPP; writing—original draft preparation: IRG; writing—review and editing: IRG, GO; visualization: IRG, GO; supervision: IRG, GO; project administration: GO; funding acquisition: IRG, GO. All authors have read and agreed to the published version of the manuscript.
Corresponding author
Correspondence to Gabriel Olveira.
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Competing interests
IRG has received honorarium support for a presentation from Adventia Pharma. GO has received occasional honorarium support for presentations, meeting attendance, and travel from Adventia Pharma. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest.
Ethics approval and consent to participate
The study was conducted in accordance with the Declaration of Helsinki, and approved by the Malaga Provincial Research Ethics Committee on 30 September 2021, code 1735-N-21. Informed consent was obtained from all subjects included in the study. The material used in this article is in the public domain or is under an open licence that allows its reproduction. Every effort has been made to properly attribute the original source of the material used.
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Informed consent was obtained from all subjects involved in the study. In the case of minors, the informed consent was signed by their legal representative.
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Ruiz García, I., Porras Pérez, N., García Torres, F. et al. Comparison of the digestive tolerance of an oligomeric versus a polymeric oral nutritional supplement in people with anorexia nervosa. A randomised crossover clinical trial. Eur J Clin Nutr (2025). https://doi.org/10.1038/s41430-025-01608-y
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Received:19 December 2023
Revised:13 February 2025
Accepted:18 March 2025
Published:31 March 2025
DOI:https://doi.org/10.1038/s41430-025-01608-y
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