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Effects of probiotic and prebiotic supplements on serum inflamatory factors, tryptophan, cortisol, leptin and appetite in patients with major depressive disorder

Protocol summary

Summary
The aim of the current study is to investigate the effects of a bacterial formulation, which is effective on hypothalamus-hypophysis axis, and a prebiotic, which enhances the growth of thses bactrial strains (galactooligsaccharide), on depression and appetite score. Inclusion crateria: Melancolic type of major depression with mild to moderate level; consumption of one the fallowing anti-depressant drugs: sertraline, fluoxetine and citalopram; range for ages 18 to 50 years. Exlusion crateria: people who have consumed probiotic products regularly 2 month before the intervention; Omega 3 and anti-oxidant supplements consumption 4-6 weeks befor the beginning of intervention and following a specific diet. The sample size of the study is 90. The participants randomly allocate into three groups. Each group intakes one of the following intervention for two months: probiotic supplement (containing Lactobacillus helveticus, Bifidobacterium longum), prebiotic supplement and placebo. The following outcomes will be measured: serum levels of free leptin, tryptophan, inflammatory factors (IL-6, IL_1β and TNF-α), fasting urinary level of cortisol, appetite and depression score.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015092924271N1
Registration date: 2015-11-29, 1394/09/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Asma Kazemi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8895 5975
Email address
kazemias@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences
Expected recruitment start date
2016-02-20, 1394/12/01
Expected recruitment end date
2016-06-19, 1395/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
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Scientific title
Effects of probiotic and prebiotic supplements on serum inflamatory factors, tryptophan, cortisol, leptin and appetite in patients with major depressive disorder
Public title
Effects of probiotic and prebiotic supplements in patients with major depressive disorder
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medicals Sciences
Street address
Tehran University of Medical Sciences, Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-11-17, 1394/08/26
Ethics committee reference number
IR.TUMS.REC.1394.1190

Health conditions studied

1

Description of health condition studied
major depressive disoreders
ICD-10 code
F32
ICD-10 code description
Depressive episode

2

Description of health condition studied
Mild depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode

3

Description of health condition studied
Moderate depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode

Primary outcomes

1

Description
serum free leptin
Timepoint
before and after the intervention
Method of measurement
serum level will be measured with sensetive ELISA

2

Description
TNF-α
Timepoint
before and after the intervention
Method of measurement
serum level will be measured with ELISA

3

Description
IL_1β
Timepoint
before and after the intervention
Method of measurement
serum level will be measured with ELISA

4

Description
IL-6
Timepoint
before and after the intervention
Method of measurement
serum level will be measured with ELISA

5

Description
tryptophane
Timepoint
before and after the intervention
Method of measurement
serum level will be measured with HPLC

6

Description
cortisol
Timepoint
before and after the intervention
Method of measurement
mass specterometry will be used for measuring urinary level of cortisol

7

Description
depression
Timepoint
before and after the intervention
Method of measurement
Beck questionaire

8

Description
appetite score
Timepoint
before and after the intervention
Method of measurement
visual analogue scale questionaire

Secondary outcomes

1

Description
weight
Timepoint
before and after the intervention
Method of measurement
Weighing scale

2

Description
energy intake
Timepoint
before and after the intervention
Method of measurement
24-hour recall

3

Description
physical activity
Timepoint
before and after the intervention
Method of measurement
IPAQ questionnaire

4

Description
height
Timepoint
before and after the intervention
Method of measurement
height scale

Intervention groups

1

Description
Probiotic supplement 5gr/day after launch for 2 month. The supplement contains: lactobacillus helveticus R0052, bifidobacterium longum R0175
Category
Treatment - Drugs

2

Description
Prebiotic supplement (galacto-oligosaccharide) 4.8 gr/day after the launch for 2 month (6 gr galacto-oligosaccharide powder with 80% purity)
Category
Treatment - Drugs

3

Description
Placebo/ 6 gr/ day malto dexestrine, after the launch
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
psychiatrist clinic
Full name of responsible person
Asma Kazemi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Masud Yunesian
Street address
Department of Environmental Health Engineering, School of Public Health
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Nutrition and dietetic school, Tehran University of medical Scienes
Full name of responsible person
Asma Kazemi
Position
Ph.D student in nutrition
Other areas of specialty/work
Street address
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetic, Tehran University of Medical Sciences, No 44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 917 702 4928
Fax
Email
kazemiasma@rocketmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
, School of Nutritional Sciences and Dietetic, Tehran University of Medical Sciences
Full name of responsible person
Asma Kazemi
Position
Ph.D student in Nutrition
Other areas of specialty/work
Street address
Department of Clinical Nutrition, School of Nutritional Sciences and Dietetic, Tehran University of Medical Sciences, No 44, Hojjat-dost Alley, Naderi St., Keshavarz Blvd
City
Tehran
Postal code
Phone
+98 917 702 4928
Fax
Email
kazemiasma@rocketmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nutrition Sciences and dietetics, Tehran University of Medical Sciences
Full name of responsible person
Asma Kazemi
Position
Ph.D student of Nutrition
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
00
Fax
Email
kazemiasma@rocketmail.comkazemias@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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