Condition 1: major depressive disoreders. Condition 2: Mild depression. Condition 3: Moderate depression. Depressive episode Mild depressive episode Moderate depressive episode
Conditions
Interventions
Intervention 1: Probiotic supplement 5gr/day after launch for 2 month. The supplement contains: lactobacillus helveticus R0052, bifidobacterium longum R0175. Intervention 2: Prebiotic supplement (gala
Treatment - Drugs
Probiotic supplement 5gr/day after launch for 2 month. The supplement contains: lactobacillus helveticus R0052, bifidobacterium longum R0175
Prebiotic supplement (galacto-oligosaccharide) 4.8 gr/day after the launch for 2 month (6 gr galacto-oligosaccharide powder with 80% purity)
Placebo/ 6 gr/ day malto dexestrine, after the launch
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: range for ages 18 to 50 years; mild to moderate melancholic type of major depression; intake of the following anti-depressant drugs: sertraline, fluoxetine and citalopram. Exclusion criteria: history of renal, hepatic, cardiovascular, respiratory diseases or food allergy; pregnancy and lactation; regular intake of probiotic less than 2 months before the beginning of the study; intake of the antioxidant or omega 3 supplements 6 weeks before the beginning of the study; alcohol intake; smoking cigarette (more than 5 Sticks during last 6 month) or tobacco (pipe and hookah at least one time during last month); any addiction to opiates; history of heart attack or stroke; following of specific diet; participation in another study during last two months; intake of drugs other than antidepressant drugs; allergy to the components of study supplements; any significant change in the diet and life style; any change in the drug regiment; inflammatory disease which last more than one week during the study; intake of antibiotics during the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum free leptin. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with sensetive ELISA.;TNF-a. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;IL_1ß. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;IL-6. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with ELISA.;Tryptophane. Timepoint: before and after the intervention. Method of measurement: serum level will be measured with HPLC.;Cortisol. Timepoint: before and after the intervention. Method of measurement: mass specterometry will be used for measuring urinary level of cortisol.;Depression. Timepoint: before and after the intervention. Method of measurement: Beck questionaire.;Appetite score. Timepoint: before and after the intervention. Method of measurement: visual analogue scale questionaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight. Timepoint: before and after the intervention. Method of measurement: Weighing scale.;Energy intake. Timepoint: before and after the intervention. Method of measurement: 24-hour recall.;Physical activity. Timepoint: before and after the intervention. Method of measurement: IPAQ questionnaire.;Height. Timepoint: before and after the intervention. Method of measurement: height scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsma Kazemi
Nutrition and dietetic school, Tehran University of medical Scienes
Outcome results
None listed