Dataset Information

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

ABSTRACT:

Background

Atypical antipsychotic medications, which are effective for the treatment of schizophrenia and bipolar disorder, are associated with features of metabolic syndrome, such as weight gain, hyperglycemia, dyslipidemia, and insulin resistance. Although there are a few studies on the effects of dietary fiber or probiotics on weight loss in obese people, no published trials have reported the efficacy of dietary fiber and probiotics on reducing atypical antipsychotic-induced weight gain.

Methods

For this 12-week randomized, double-blind, placebo-controlled study, 100 patients with a weight gain of more than 10% after taking atypical antipsychotic medications were recruited. Participants were randomized to four groups as follows: probiotics (840?mg twice daily (bid)) plus dietary fiber (30?g bid), probiotics (840?mg bid) plus placebo, placebo plus dietary fiber (30?g bid), or placebo group. The primary outcome was the change in body weight. Secondary outcomes included changes in metabolic syndrome parameters, appetite score, biomarkers associated with a change in weight, and gut microbiota composition and function.

Discussion

To date, this is the first randomized, placebo-controlled, double-blinded trial investigating the efficacy of dietary fiber and probiotics alone and in combination to reduce metabolic side effects induced by atypical antipsychotic medications. If effective, it is possible to conclude that dietary fiber and probiotics can reduce atypical antipsychotic-induced metabolic side effects.

Trial registration number

ClinicalTrials.gov NCT03379597 . Registered on 19 November 2017.

SUBMITTER: Liu C

PROVIDER: S-EPMC7903643 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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 C Kang Dongyu D Xiao Jingmei J Huang Yuyan Y Peng Xingjie X Wang Weiyan W Xie Peng P Yang Ye Y Zhao Jingping J Wu Renrong R

Trials 20210223 1

<h4>Background</h4>Atypical antipsychotic medications, which are effective for the treatment of schizophrenia and bipolar disorder, are associated with features of metabolic syndrome, such as weight gain, hyperglycemia, dyslipidemia, and insulin resistance. Although there are a few studies on the effects of dietary fiber or probiotics on weight loss in obese people, no published trials have reported the efficacy of dietary fiber and probiotics on reducing atypical antipsychotic-induced weight ga ...[more]

PMID: 33622382

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Project description:This resident physician-led quality improvement project was conducted with aims to improve the health of youth prescribed atypical antipsychotic medications by increasing physician monitoring for metabolic side effects, while simultaneously educating trainees in quality improvement methodology. The plan, do, study, act quality improvement framework was utilized. Baseline metabolic monitoring rates of patients prescribed atypical antipsychotic medications in the two psychiatry resident outpatient clinics were obtained. Rates were stratified based on time on medication (<1 year, ?1 year) and parameter monitored. Metabolic monitoring rates subsequent to targeted changes were obtained. Problem solving with residents revealed barriers to monitoring, such as limited awareness of specific guideline recommendations and lack of convenient access to medical equipment (calibrated scales). Residents received education about atypical antipsychotic monitoring guidelines and side effect treatment. Residents were provided with calibrated scales. Atypical antipsychotic monitoring templates were introduced. Online surveys using were conducted to determine self-reported baseline-monitoring rates and comfort with guidelines following targeted change. The baseline metabolic monitoring rates of patients prescribed atypical antipsychotic medications was 9% (range: 0 to 17.6%) for youth in their first year taking an atypical antipsychotic medication and 58.9% (range: 29% to 100%) in subsequent years on medication. The results of relatively easy changes resulted in modest improvement in monitoring rates. The metabolic monitoring rate of a patient initiated on an atypical antipsychotic medication was 29% after targeted quality improvement measures were employed. Following quality improvement changes, residents reported increased knowledge about guidelines and increased monitoring for side effects. Use of a standardized data collection instrument to track monitoring of patients increased from 0% to 70% (range: 30% to 90%). Quality improvement projects provide an avenue with which to improve atypical antipsychotic monitoring rates. Through active participation in quality improvement projects, psychiatry residents may be taught to employ quality improvement methodology.

Project description:BACKGROUND:Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechanisms are not fully identified. Recent evidence suggests the modulatory effect of synbiotics on gut microbiota and the contribution of these agents in ameliorating symptoms of many psychiatric diseases. To date, no randomized controlled trial has been performed to establish the feasibility and efficacy of this intervention targeting the reduction of impulsivity and compulsivity. We hypothesize that supplementation with synbiotics may be an effective treatment in adults with high levels of impulsivity and/or compulsivity. METHODS/DESIGN:This is a prospective, multicenter, double-blind, randomized controlled trial with two arms: treatment with a synbiotic formula versus placebo treatment. The primary outcome is the response rate at the end of the placebo-controlled phase (response defined as a Clinical Global Impression-Improvement Scale score of 1 or 2?=?very much improved or much improved, plus a reduction in the Affective Reactivity Index total score of at least 30% compared with baseline). A total of 180 participants with highly impulsive behavior and a diagnosis of attention deficit/hyperactivity disorder (ADHD) and/or borderline personality disorder, aged 18-65?years old, will be screened at three study centers. Secondary outcome measures, including changes in general psychopathology, ADHD symptoms, neurocognitive function, somatic parameters, physical activity, nutritional intake, and health-related quality of life, will be explored at assessments before, during, and at the end of the intervention. The effect of the intervention on genetics, microbiota, and several blood biomarkers will also be assessed. Gastrointestinal symptoms and somatic complaints will additionally be explored at 1-week follow-up. DISCUSSION:This is the first randomized controlled trial to determine the effects of supplementation with synbiotics on reducing impulsive and compulsive behavior. This clinical trial can contribute to explaining the mechanisms involved in the crosstalk between the intestinal microbiome and the brain. If effects can be established by reducing impulsive and compulsive behavior, new cost-effective treatments might become available to these patients. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03495375. Registered on 26 February 2018.

Dataset Information

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

Background

Methods

Discussion

Trial registration number

Publications

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

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