Condition 1: Major depressive disorder, mild. Condition 2: Major depressive disorder, moderate. Major depressive disorder, recurrent, mild Major depressive disorder, recurrent, moderate
Conditions
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Non-menopausal women aged 20-50 years Body Mass Index (BMI) range: 30-40 Kg/m2 Suffering from mild to moderate depression based on DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria, as diagnosed by a psychiatrist willingness to participate in the study
Exclusion criteria
Exclusion criteria: Pregnancy or lactation Co-morbidity with other major psychological or neurological diseases including psychosis, multiple sclerosis (MS), bipolar disorder Suffering from thyroid dysfunctions Drug abuse Smoking A history of following particular diets Using synthetic or herbal drugs for weight loss Changes in type or dosage of any other medications or nutritional supplements, during the study Using fiber supplements or taking more than 25 grams of dietary fiber per day Regular use of prebiotic or probiotic products or supplements, or antibiotic drugs during 2 months prior to the study or during the study Any significant events during the study, which might affect the patient's psychological health
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anthropometric measures. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumferences by a tape measure. Calculation of waist to hip ratio (WHR) by dividing waist circumference by hip circumference, and body mass index (BMI) by dividing weight (Kg) by height squared (m2).;Body composition. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW).;Resting metabolic rate. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Indirect calorimetry.;Gut permeability. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of Serum Zonulin by ELISA method.;Endotoxemia. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum lipopolysaccharide (LPS) by ELISA.;Blood pressure. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: stethoscope.;Blood glucose. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic method.;Lipid profile. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation.;Inflammatory indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum hs-CRP by immunoturbidimetry, and serum TNF-a and IL-10 by ELISA.;State-trait anxiety. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Spielberger State-Trait Anxiety Inventory (STAI-Y).;Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Beck Depression Inventory (BDI-II).;Depression remission. Ti | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactElnaz Vaghef-Mehrabany
Tabriz University of Medical Sciences
Outcome results
None listed