Randomized clinical trial evaluating the efficacy of synbiotic supplementation on serum endotoxin and trimethylamine N-oxide levels in patients with dyslipidaemia

Shekoufeh Salamat; Alireza Jahan-Mihan; Mohammad Reza Tabandeh; Anahita Mansoori

doi:10.5114/amsad/178106

Randomized clinical trial evaluating the efficacy of synbiotic supplementation on serum endotoxin and trimethylamine N-oxide levels in patients with dyslipidaemia

Arch Med Sci Atheroscler Dis. 2024 Feb 1:9:e18-e25. doi: 10.5114/amsad/178106. eCollection 2024.

Authors

Shekoufeh Salamat^{1

2}, Alireza Jahan-Mihan³, Mohammad Reza Tabandeh^{4

5}, Anahita Mansoori¹

Affiliations

¹ Nutrition and Metabolic Diseases Research Centre, Clinical Sciences Research Centre, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
² Student Research Committee, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
³ Department of Nutrition and Dietetics, University of North Florida, Jacksonville, FL, USA.
⁴ Department of Biochemistry and Molecular Biology, Faculty of Veterinary Medicine, Shahid Chamran University of Ahvaz, Ahvaz, Iran.
⁵ Stem Cells and Transgenic Technology Research Center, Shahid Chamran University of Ahvaz, Iran.

Abstract

Introduction: Elevated serum endotoxin and trimethylamine N-oxide (TMAO) are associated with metabolic disorders including dyslipidaemia and insulin resistance. This study aimed to evaluate the impact of a 12-week treatment with a synbiotic supplement on serum endotoxin and TMAO levels in patients diagnosed with dyslipidaemia.

Material and methods: A total of 56 patients who met the study inclusion criteria were recruited in this randomized, double-blind clinical trial. Participants were randomly assigned into intervention and control groups and received either synbiotic or placebo sachets twice a day for 12 weeks. The sociodemographic data, food intake, physical activity, and anthropometric indices of participants were assessed before and after intervention. Serum endotoxin, TMAO, and fasting blood glucose (FBG) levels were measured at the baseline and end of the study.

Results: No significant difference in the baseline characteristics of participants in the 2 groups was observed. After the 12 weeks of intervention, the mean of serum endotoxin (p < 0.0001), TMAO (p < 0.0001), and FBG (p < 0.0001) was decreased in patients who received synbiotic supplements while no significant change was observed in the control group. Moreover, a significant positive correlation between changes in endotoxin (r = 0.41, p = 0.041) and TMAO (r = 0.40, p = 0.047) with FBG changes was observed.

Conclusions: A significant reduction in serum endotoxin and TMAO levels, as well as improvements in FBG, following 12 weeks of supplementation with synbiotics, may offer a potential approach for improving metabolic status in patients with dyslipidaemia.

Keywords: dyslipidaemia; endotoxin; gut microbiota; gut permeability; synbiotic; trimethylamine n-oxide.