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

NCT03552237 | Unknown

• 1 other identifier: 106035
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Schizophrenia; Central Obesity

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

dietary fiber intervention group

EXPERIMENTAL

Dietary Supplement: dietary fiber

Interventions

dietary fiber DIETARY_SUPPLEMENT

We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.

dietary fiber intervention group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Schizophrenia inpatients
• Overweight and with central obesity
• agree to sign informed consent

You may not qualify if:

• Diagnosis of IBS
• Systemic antibiotic use during the past 4 weeks
• Excessive water intake

Sponsors & Collaborators

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

MeSH Terms

Conditions

Schizophrenia; Obesity, Abdominal

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of General Psychiatry Department

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 11, 2018
• Study Start: June 20, 2018
• Primary Completion: September 20, 2018
• Study Completion: December 30, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06