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PreprintCited by 5Pharmacology and Obesity TreatmentSilymarin and Mushroom PoisoningGut microbiota and health

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Effect of Silibinin on Human Pancreatic Lipase Inhibition and Gut Microbiota in Healthy Volunteers: A Randomized Controlled Trial

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Ponce Martínez, Cristina, Murcia García, Elena, Pérez Sánchez, Horacio, Milagro, Fermín I., Riezu-Boj, José I., Ramos Molina, Bruno, Gómez Gallego, María, Zamora, Salvador, Cañavate Cutillas, Rubén, Hernández Morante, Juan José·2024·International Journal of Molecular Sciences
DOI 10.20944/preprints202410.1784.v1PMC PMC11640983

Preprint — published as 10.3390/ijms252312853

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Abstract

Thistle (Onopordum acanthium) has been traditionally employed for liver protection, however, we recently identified silibinin, the main bioactive compound of thistle extract, as an in vitro pancreatic lipase inhibitor, which suggested a potential role as anti-obesity agent. This study aimed to assess, in vivo, the efficacy, safety, and effects of silibinin on human lipase. As a secondary objective, we evaluated potential changes on gut microbiota after silibinina treatment. A randomized trial comparing 150mg/silibinin, 300mg/silibinin, and a thistle extract (equivalent to 150 mg/silibinin) with placebo and orlistat/120mg was conducted. Fecal fat excretion, clinical parameters, and microbiota changes were analyzed. Orlistat showed the highest fecal fat excretion, although thistle extract had similar results (p = 0.582). The 150 mg/silibinin group reported the fewest adverse effects. Both silibinin and orlistat reduced plasma triglycerides (p=0.016) and waist circumference (p=0.001). Specific microbiota changes, such as increases in Mycobacteriaceae and Veillonellaceae, were associated with higher fat excretion. Silibinin proved to be safe and effective for obesity, with minimal adverse effects and no significant changes in microbiota diversity. Further studies are needed to explore its microbiota-related benefits.

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Figure 1 Boxplots showing individual values of the plasma triglycerides throughout the different interventions. Statistical differences were evaluated by a one-way ANOVA. FDR was conducted to control for multiple comparisons. Significance level was p < 0.050, after adjustment, in all cases. Boxplots with different letters indicate statistically significant differences after adjustment.
Figure 1 Boxplots showing individual values of the plasma triglycerides throughout the different interventions. Statistical differences were evaluated by a one-way ANOVA. FDR was conducted to control for multiple comparisons. Significance level was p < 0.050, after adjustment, in all cases. Boxplots with different letters indicate statistically significant differences after adjustment.CC BY · PubMed Central
Figure 2 Boxplots showing individual values of waist circumference throughout the different interventions. Statistical differences were evaluated by a one-way ANOVA. FDR was conducted to control for multiple comparisons. Significance level was p < 0.050, after adjustment, in all cases Boxplots with different letters indicate statistically significant differences after adjustment.
Figure 2 Boxplots showing individual values of waist circumference throughout the different interventions. Statistical differences were evaluated by a one-way ANOVA. FDR was conducted to control for multiple comparisons. Significance level was p < 0.050, after adjustment, in all cases Boxplots with different letters indicate statistically significant differences after adjustment.CC BY · PubMed Central
Figure 3 Faecal fat excretion (mean ± sd of the 3 days of treatment) measurements of the different interventions carried out in the present study. Faecal fat excretion was estimated daily, and faecal fat was estimated as the mean fat excretion of the three days. Therefore, a nested one-way ANOVA was conducted. FDR was calculated to control for multiple comparisons; however, there were no statistically significant differences among treatments.
Figure 3 Faecal fat excretion (mean ± sd of the 3 days of treatment) measurements of the different interventions carried out in the present study. Faecal fat excretion was estimated daily, and faecal fat was estimated as the mean fat excretion of the three days. Therefore, a nested one-way ANOVA was conducted. FDR was calculated to control for multiple comparisons; however, there were no statistically significant differences among treatments.CC BY · PubMed Central
Figure 4 Flow diagram of the present study.
Figure 4 Flow diagram of the present study.CC BY · PubMed Central

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Metadata

Authors
Ponce Martínez, C., Murcia García, E., Pérez Sánchez, H., Milagro, F. I., Riezu-Boj, J. I., Ramos Molina, B., Gómez Gallego, M., Zamora, S., Cañavate Cutillas, R., & Hernández Morante, J. J.
Affiliations
Universidad de Murcia (ES)
ORCID
Venue
International Journal of Molecular Sciences
Publisher
MDPI AG
Published
2024-10-23
Volume
25
Issue
23
Pages
12853-12853
ISSN
1422-0067 (ISSN-L)
DOI
10.20944/preprints202410.1784.v1
PMC
PMC11640983
OpenAlex
W4404861727
Cited by
5
References
43
Citations by year
2025: 5
FWCI
1.41
Type
journal article
Language
en
Open access
Licence
Locations
  • International Journal of Molecular Sciences (publishedVersion, cc-by)
  • Preprints.org (acceptedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • RIUCAM (submittedVersion, cc-by-nd)
Funders
  • Fundación Séneca (21646/PDC/21)
  • Universidad de Málaga
  • Universidad de Murcia
  • Centro de Investigación Biomédica en Red-Fisiopatología de la Obesidad y Nutrición (CP19/00098, CB12/03/30002, # 21646/PDC/21)
  • Instituto de Salud Carlos III (# 21646/PDC/21, CB12/03/30002, CP19/00098)
  • European Regional Development Fund
  • Centro de Investigaciones Energéticas, Medioambientales y Tecnológicas
Topics
  • Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
  • Health Sciences › Medicine › Hepatology › Silymarin and Mushroom Poisoning
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
Keywords
silibinin, Onopordum acanthium, pancreatic lipase inhibition, gut microbiota, obesity, orlistat, fecal fat excretion, plasma triglycerides, waist circumference, Mycobacteriaceae, Veillonellaceae, drug safety
MeSH terms
Gastrointestinal Microbiome, Silybin, Orlistat, Adult, Feces, Female, Humans, Lipase, Male, Middle Aged, Pancreas, Silymarin, Anti-Obesity Agents, Healthy Volunteers

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CoChat. (2026). Citation check: Effect of Silibinin on Human Pancreatic Lipase Inhibition and Gut Microbiota in Healthy Volunteers: A Randomized Controlled Trial. https://app.cochat.ai/papers/10.20944/preprints202410.1784.v1
The paper
Ponce Martínez, C., Murcia García, E., Pérez Sánchez, H., Milagro, F. I., Riezu-Boj, J. I., Ramos Molina, B., Gómez Gallego, M., Zamora, S., Cañavate Cutillas, R., & Hernández Morante, J. J. (2024). Effect of Silibinin on Human Pancreatic Lipase Inhibition and Gut Microbiota in Healthy Volunteers: A Randomized Controlled Trial. International Journal of Molecular Sciences. https://doi.org/10.20944/preprints202410.1784.v1