Effect of prebiotic supplementation in treatment of major depressive disorder

The effects of a weight loss diet with or without prebiotic supplementation on oxidative stress indices and depression severity in obese women suffering from major depressive disorder

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20100209003320N14

Enrollment

Registered

2018-04-12

Start date

2018-04-21

Completion date

Unknown

Last updated

2018-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Major depressive disorder, mild. Condition 2: Major depressive disorder, moderate. Major depressive disorder, recurrent, mild Major depressive disorder, recurrent, moderate

Interventions

Intervention 1: Intervention group: Patients in this group will receive weight loss diet and prebiotic supplements for 8 weeks. Prebiotic supplement is a sachet containing 10 grams of inulin (a produc

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 Having received SSRI and SNRI drugs for at least 2 months 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 medication protocol for major depressive disorder, during the study Changes in type or dosage of any other medications 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

Design outcomes

Primary

Measure	Time frame
Oxidative stress indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum levels of Total antioxidant capacity (TAC), malondialdehyde (MDA) and nitric oxide (NO) by spectrophotometry, serum isoprostane-F2 by ELISA, and arylesterase activity of paraoxonase enzyme by using phenyl acetate through spectrophotometry.;Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Montgomery–Asberg Depression Rating Scale (MADRS).	—

Measure

Time frame

Oxidative stress indices. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Measurement of serum levels of Total antioxidant capacity (TAC), malondialdehyde (MDA) and nitric oxide (NO) by spectrophotometry, serum isoprostane-F2 by ELISA, and arylesterase activity of paraoxonase enzyme by using phenyl acetate through spectrophotometry.;Depression severity. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Montgomery–Asberg Depression Rating Scale (MADRS).

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactElnaz Vaghef-Mehrabany

Tabriz University of Medical Sciences

elnaz.vaghef@gmail.com+98 41 3335 7582

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026