Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients

The Effect of Dietary Fiber Supplement on the Intestinal Microbiota Among Schizophrenia Patients With Central Obesity: a Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Schizophrenia; Central Obesity
• Intervention / Treatment: Dietary supplement: dietary fiber

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Schizophrenia inpatients
2. Overweight and with central obesity
3. agree to sign informed consent

Exclusion Criteria:

1. Diagnosis of IBS
2. Systemic antibiotic use during the past 4 weeks
3. Excessive water intake

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline in microbiota composition at week 4	Fecal samples from participants before and after the intervention will be processed for microbiota analysis	4 weeks

Collaborators and Investigators

• Sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan

Study record dates

Study Major Dates

• Study Start (Anticipated): June 20, 2018
• Primary Completion (Anticipated): September 20, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 8, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: June 8, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Schizophrenia Spectrum and Other Psychotic Disorders; Obesity; Schizophrenia; Obesity, Abdominal
• Other Study ID Numbers: 106035

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No