Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial

Liu, Chenchen; Kang, Dongyu; Xiao, Jianru; Huang, Yuyan; Peng, Xing-Jie; Wang, Weiyan; Xie, Peng; Yang, Ye; Zhao, Jingping; Wu, Renrong

doi:10.1186/s13063-021-05123-w

Cited by 9 publications

(12 citation statements)

References 25 publications

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“… 90 Currently, a prospective study using a combination of probiotics (combination of Bifidobacterium , Lactobacillus , and Enterococcus ) and prebiotic (dietary fiber – maltodextrin and Perfect dietary fiber drink) formulations in 100 patients receiving SGAs with >10% weight gain is underway. 87 This study will prove insightful in understanding the role of probiotic and prebiotic supplementation in SCZ patients including its effect on weight gain, metabolic syndrome parameters, appetite, and GMB composition. 87 …”

Section: Resultsmentioning

confidence: 96%

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Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review

Singh

Stogios

Smith

et al. 2022

Therapeutic Advances in Psychopharmacology

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Schizophrenia (SCZ) is a severe mental disorder with high morbidity and lifetime disability rates. Patients with SCZ have a higher risk of developing metabolic comorbidities such as obesity and diabetes mellitus, leading to increased mortality. Antipsychotics (APs), which are the mainstay in the treatment of SCZ, increase the risk of these metabolic perturbations. Despite extensive research, the mechanism underlying SCZ pathophysiology and associated metabolic comorbidities remains unclear. In recent years, gut microbiota (GMB) has been regarded as a ‘chamber of secrets’, particularly in the context of severe mental illnesses such as SCZ, depression, and bipolar disorder. In this scoping review, we aimed to investigate the underlying role of GMB in the pathophysiology of SCZ and metabolic alterations associated with APs. Furthermore, we also explored the therapeutic benefits of prebiotic and probiotic formulations in managing SCZ and AP-induced metabolic alterations. A systematic literature search yielded 46 studies from both preclinical and clinical settings that met inclusion criteria for qualitative synthesis. Preliminary evidence from preclinical and clinical studies indicates that GMB composition changes are associated with SCZ pathogenesis and AP-induced metabolic perturbations. Fecal microbiota transplantation from SCZ patients to mice has been shown to induce SCZ-like behavioral phenotypes, further supporting the plausible role of GMB in SCZ pathogenesis. This scoping review recapitulates the preclinical and clinical evidence suggesting the role of GMB in SCZ symptomatology and metabolic adverse effects associated with APs. Moreover, this scoping review also discusses the therapeutic potentials of prebiotic/probiotic formulations in improving SCZ symptoms and attenuating metabolic alterations related to APs.

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Section: Resultsmentioning

confidence: 96%

“… 87 This study will prove insightful in understanding the role of probiotic and prebiotic supplementation in SCZ patients including its effect on weight gain, metabolic syndrome parameters, appetite, and GMB composition. 87 …”

Section: Resultsmentioning

confidence: 96%

Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review

Singh

Stogios

Smith

et al. 2022

Therapeutic Advances in Psychopharmacology

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“…The analyses were performed using the Statistical Package for Social Sciences, version 25.0 (SPSS Inc., Chicago, Illinois). A statistical analysis plan was published before in the protocol [ 21 ]. For participants with at least one follow-up visit (118 of 136), the last-observation carried-forward method (intention-to-treat analysis) was employed for efficacy analysis, and all the randomized 136 patients were included for safety analysis.…”

Section: Methodsmentioning

confidence: 99%

“…Written informed consents were obtained from all participants before undergoing examinations. The detailed study protocol has been published previously [ 21 ]. Trial registration clinicaltrials.gov Identifier: NCT03379597.…”

Section: Methodsmentioning

confidence: 99%

The effects of probiotics plus dietary fiber on antipsychotic-induced weight gain: a randomized clinical trial

et al. 2022

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Probiotics plus dietary fiber has demonstrated efficacy in improving metabolic abnormalities. However, the efficacy of probiotics and dietary fiber as well as their association with microbiota in attenuating antipsychotic-induced weight gain and metabolic disturbance remains poorly understood. Here we analyzed results from the double-blind, randomized, placebo-controlled study to compare and evaluate the effects of probiotics, dietary fiber, and their combination for antipsychotic-induced weight gain in patients with a severe mental disorder. We found that probiotics plus dietary fiber was significantly superior to probiotics alone, dietary fiber only, and the placebo for weight, BMI, and total cholesterol reduction; insulin resistance was worse in the placebo group, with significant increases during the 12-week treatment; probiotics plus dietary fiber significantly reduced weight and prevented further deterioration of metabolic disturbances; and probiotics or dietary fiber alone can prevent further weight gain. We further performed 16 S ribosomal RNA sequencing revealed an increased abundance of microbiota after probiotics plus dietary fiber treatment. Moreover, logistic regression analyses revealed that the higher richness of microbiota was associated with favorable weight loss. These findings suggested that probiotics and dietary fiber co-administration were safe and effective interventions to reduce weight gain in patients treated with antipsychotic medications.

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“…Yang et al reported that the addition of probiotics, including Bifidobacterium and Lactobacillus, was not sufficient to reduce weight gain in patients with schizophrenia, nor did it significantly improve lipid profiles (Yang et al, 2021). In comparison, the combined use of probiotics and dietary fiber was effective in reducing olanzapine-induced weight gain without any apparent adverse effects while maintaining the desired psychopathological effect (Liu et al, 2021;Huang et al, 2022a;Huang et al, 2022b). Therefore, more randomized controlled trials in humans are needed to translate beneficial findings in animals.…”

Section: Non-pharmacological Interventionsmentioning

confidence: 99%

The regulatory effects of second-generation antipsychotics on lipid metabolism: Potential mechanisms mediated by the gut microbiota and therapeutic implications

et al. 2023

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Second-generation antipsychotics (SGAs) are the mainstay of treatment for schizophrenia and other neuropsychiatric diseases but cause a high risk of disruption to lipid metabolism, which is an intractable therapeutic challenge worldwide. Although the exact mechanisms underlying this lipid disturbance are complex, an increasing body of evidence has suggested the involvement of the gut microbiota in SGA-induced lipid dysregulation since SGA treatment may alter the abundance and composition of the intestinal microflora. The subsequent effects involve the generation of different categories of signaling molecules by gut microbes such as endogenous cannabinoids, cholesterol, short-chain fatty acids (SCFAs), bile acids (BAs), and gut hormones that regulate lipid metabolism. On the one hand, these signaling molecules can directly activate the vagus nerve or be transported into the brain to influence appetite via the gut–brain axis. On the other hand, these molecules can also regulate related lipid metabolism via peripheral signaling pathways. Interestingly, therapeutic strategies directly targeting the gut microbiota and related metabolites seem to have promising efficacy in the treatment of SGA-induced lipid disturbances. Thus, this review provides a comprehensive understanding of how SGAs can induce disturbances in lipid metabolism by altering the gut microbiota.

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Dietary fiber and probiotics for the treatment of atypical antipsychotic-induced metabolic side effects: study protocol for a randomized, double-blind, placebo-controlled trial

Cited by 9 publications

References 25 publications

Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review

Gut microbiome in schizophrenia and antipsychotic-induced metabolic alterations: a scoping review

The effects of probiotics plus dietary fiber on antipsychotic-induced weight gain: a randomized clinical trial

The regulatory effects of second-generation antipsychotics on lipid metabolism: Potential mechanisms mediated by the gut microbiota and therapeutic implications

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