Probiotic applications in obesity and related mood disorders

Phase 3

• Conditions: Obesity with mood disorders.; Obesity due to excess calories; E66.0

• Registration Number: IRCT20191127045525N1
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

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

pregnancy, any significant change in diet or physical activity, starting new drugs or antibiotics, and not intending to continue study protocols.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory (BDI) score. Timepoint: Before commencement and after 12 weeks of intervention. Method of measurement: Beck Depression Questionnaire.