National Clinical Research Center for Mental Disorders, and Department of Psychiatry, The Second Xiangya Hospital of Central South University, Changsha, 410011, Hunan, China.
Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai, 200031, China.
Trials. 2021 Feb 23;22(1):159. doi: 10.1186/s13063-021-05123-w.
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.
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.
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.
ClinicalTrials.gov NCT03379597 . Registered on 19 November 2017.
非典型抗精神病药物对精神分裂症和双相情感障碍的治疗有效，但会引起代谢综合征的特征，如体重增加、高血糖、血脂异常和胰岛素抵抗。虽然有一些关于膳食纤维或益生菌对肥胖者减肥效果的研究，但没有发表的试验报告膳食纤维和益生菌对减轻非典型抗精神病药物引起的体重增加的疗效。
在这项为期 12 周的随机、双盲、安慰剂对照研究中，招募了 100 名服用非典型抗精神病药物后体重增加超过 10%的患者。参与者被随机分为四组：益生菌（840mg，每日两次（bid））加膳食纤维（30g，bid）、益生菌（840mg，bid）加安慰剂、安慰剂加膳食纤维（30g，bid）或安慰剂组。主要结局是体重变化。次要结局包括代谢综合征参数的变化、食欲评分、与体重变化相关的生物标志物、肠道微生物群组成和功能的变化。
迄今为止，这是第一项单独和联合使用膳食纤维和益生菌来减少非典型抗精神病药物引起的代谢副作用的随机、安慰剂对照、双盲试验。如果有效，可以得出结论，膳食纤维和益生菌可以减轻非典型抗精神病药物引起的代谢副作用。
ClinicalTrials.gov NCT03379597。注册于 2017 年 11 月 19 日。
