Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients
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|ClinicalTrials.gov Identifier: NCT03552237|
Recruitment Status : Unknown
Verified June 2018 by C Lin, TsaoTun Psychiatric Center, Department of Health, Taiwan.
Recruitment status was: Not yet recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Background There has been much interest in the relationship between the types of gut microbiota and the development of obesity in recent years. It has been reported that the proportions of Firmicutes and Bacteroidetes differ between obese and normal weight human subjects. Human intestinal microbiota compositions have been found to be associated with long-term dietary habits and lifestyle. However, an increasing number of researches show that intestinal microbiota composition may be affected after short-term diet intervention. Importantly, obesity and metabolic problems play important roles in morbidity and mortality of schizophrenia patients. Human intestinal microbiota compositions related with obesity may impact the heath of this population. Therefore, we searched current advances about the connection of obesity, intestinal microbiota compositions, and diet in schizophrenia to conduct a clinical research focus on the effect of high fiber diet on the intestinal microbiota of schizophrenia patients with central obesity.
Method We will investigate in a 4-week intervention whether consumption of dietary fiber supplement(Inulin) affect the microbiota composition in schizophrenia inpatients with central obesity. Fecal samples from participants before and after the intervention will be processed for the microbiota analysis.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Central Obesity||Dietary Supplement: dietary fiber||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study|
|Estimated Study Start Date :||June 20, 2018|
|Estimated Primary Completion Date :||September 20, 2018|
|Estimated Study Completion Date :||December 30, 2018|
|Experimental: dietary fiber intervention group||
Dietary Supplement: dietary fiber
We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.
- Changes from baseline in microbiota composition at week 4 [ Time Frame: 4 weeks ]Fecal samples from participants before and after the intervention will be processed for microbiota analysis