Obesity with mood disorders. Obesity due to excess calories
Conditions
Interventions
Intervention 1: Intervention group will recieve 1 gram Capsule containing lactobacillus and bifidobacteria at dose of 3*10 9 CFU + one capsule containing 1 gram magnesium chloride providing 250 millig
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: ?Willing to participate in the study Age range of 18 to 50 years Body Mass Index (BMI) =30 and waist circumference (WC) more than 85cm in women and 102 cm in men Beck Depression Inventory (BDI) scores ranging between 17 to 40 Not taking probiotic supplements in the last 2 months and antibiotics in the last 3 months Absence of chronic liver, kidney, cardiovascular, GI and infectious diseases as well as diabetes, and severe neurological and psychiatric disorders. Not using anti-depressants Not using antioxidants, omega-3 and magnesium supplements less than one month prior to study commencement Not regular use of steroid and non-steroid anti-inflammatory drugs No regular alcohol drinking or smoking, No opioid addiction No history of heart attack, not being pregnant or intending pregnancy, not being in breastfeeding or menopausal states.
Exclusion criteria
Exclusion criteria: pregnancy, any significant change in diet or physical activity, starting new drugs or antibiotics, and not intending to continue study protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory (BDI) score. Timepoint: Before commencement and after 12 weeks of intervention. Method of measurement: Beck Depression Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck Anxiety Inventory (BAI) score. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Beck anxiety questionnaire.;Plasma Zonulin Levels. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.;Plasma Endotoxin. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.;Some Stool Bacterial populations. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Real time PCR.;Waist. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Tape meter.;Weight. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).;Body mass index. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).;Fat mass. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).;Fat free mass. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Body analyzer (Inbody).;Quality of life. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: qol-12 questionnaire.;Depression . stress and anxiety scores. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: DASS anxiety, stress & depression questionnaire.;Fasting serum cortisol. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.;Fasting blood glucose. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: Autoanalyzer.;Fasting serum insulin. Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: ELIZA.;Homeostatic Model Assessment for Insulin Resistance (HOMAIR). Timepoint: Before commencement and 9 weeks after intervention. Method of measurement: FORMULA.;Quantitative insulin-sensitivity check index (QUICKI). Timepoint: Before commenc | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSepideh Mahboobi
Shiraz University of Medical Sciences
Outcome results
None listed