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Randomized Controlled Trial
. 2025 May 21;26(10):4920.
doi: 10.3390/ijms26104920.

Rapid Reduction of Pro-Inflammatory Cytokines with an Oral Topical Composition Comprising Olive Oil, Trimethylglycine and Xylitol: A Randomized Double-Blind Controlled Trial

José López-López  1   2   3 , José M Reuss  4 , Teresa Vinuesa-Aumedes  5 , Sonia Egido-Moreno  1 , Xavier Roselló-Llabres  1 , Tanya Pereira-Riveros  5 , Debora Reuss  6 , Laura Alonso-Gamo  7 , Beatriz Rodríguez-Vilaboa  6   8   9
Affiliations
Randomized Controlled Trial

Rapid Reduction of Pro-Inflammatory Cytokines with an Oral Topical Composition Comprising Olive Oil, Trimethylglycine and Xylitol: A Randomized Double-Blind Controlled Trial

José López-López et al. Int J Mol Sci. .

Abstract

An underlying pro-inflammatory status is related to recurrence and persistence of inflammatory susceptibility in obesity and periodontitis, two of the most prevalent chronic inflammatory diseases. Elevated levels of interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α), part of the inflammatory network linking these two conditions, persist even after periodontal treatment, with high salivary cytokine levels being linked to overweight and obesity risk. This trial assessed the effect of a novel composition comprising olive oil, trimethylglycine and xylitol, delivered topically to the oral mucosa, on salivary cytokines in periodontally healthy normal and overweight/pre-obese individuals. In a randomized placebo-controlled double-blind clinical trial, adult patients were randomly assigned to use a test toothpaste (intervention group, IG) or a placebo toothpaste (control group, CG) three times a day for 1 month. Primary outcomes were levels of salivary cytokines IL-1β, TNF-α and interleukin-4 (IL-4). Significant differences between IG and CG were observed for IL-1β (p = 0.003; Z = 2.901; r = 0.62) and TNF-α (p = 0.001; Z = 3.23; r = 0.69), but not for IL-4 (p = 0.203; Z = 1.321; r = 0.28). A significant reduction in IL-1β (p = 0.008) and a near significant reduction in TNF-α (p = 0.059) was found in the IG at the end of the trial. Additionally, the effect of body mass index on cytokine levels response was analyzed. A significantly different behavior was shown between IG and CG in the overweight/pre-obesity subgroup for IL-1β (p = 0.014; Z = 2.430; r = 0.63) and TNF-α (p = 0.029; Z = 2.199; r = 0.57). Moreover, a significant decrease in IL-1β in the IG (p = 0.028) was observed. The rapid reduction in IL-1β and TNF-α after 1 month of use of the intervention composition suggests a safe and effective novel strategy for reducing pro-inflammatory cytokines that may offer an opportunity to diminish the inflammatory status in patients with overweight/pre-obesity.

Keywords: IL-1β; TNF-α; chronic inflammatory diseases; cytokines; inflammation; microbiome dysbiosis; mucosa barrier disruption; obesity; olive oil, trimethylglycine and xylitol; overweight.

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Conflict of interest statement

Beatriz Rodríguez-Vilaboa is founding member of Mucosa Innovations S.L. Mucosa Innovations is the owner and developer of technology specifically focused on mucosal cancer-therapy-related toxicities, microbiome modulation pathways and mucosa-related women’s health conditions. Mucosa Innovations S.L. is the owner of all intellectual property and technology (registered in the US Patent and Trademark Office (USPTO) and the European Patent Office (EPO)). Mucosa Innovations S.L. provided the study materials (toothpastes) tested in this clinical trial. All other authors declare no competing interests.

Figures

Figure 1
Figure 1
CONSORT 2010 flow diagram of participants through the trial.
See this image and copyright information in PMC

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