The effects of a weight loss diet with or without prebiotic supplementation on anthropometric measures, metabolic and inflammatory status, gut permeability, endotoxemia and depression status in obese women with major depression disorder
The aim of the present study is to investigate the effects of a weight loss diet with or without prebiotic supplementation on anthropometric measures, metabolic and inflammatory status, gut permeability, endotoxemia and depression status in obese women with major depression disorder.
Design
Randomized double-blind clinical trial with two arm parallel groups
Settings and conduct
The study will be conducted in the psychiatry clinic of Tabriz University of Medical Sciences, and supplementation duration will be 8 weeks. The prebiotic and placebo sachets will be coded by the person responsible for preparing them, and the main investigators and the patients will be blinded to the type of the supplement each group receives.
Participants/Inclusion and exclusion criteria
48 patients with mild to moderate depression and BMI of 30-40 Kg/m2 will be included in the study. Pregnancy, lactation, and co-morbidity of other psychological or neurological diseases are among the exclusion criteria of the study.
Intervention groups
The subjects in both groups will receive a weight loss diet considering their dietary habits. Patients in the prebiotic group will use a 10 gram inulin sachet with their lunch, daily. In the placebo group, the sachet will contain 10 grams of maltodextrin.
Main outcome variables
State-trait anxiety inventory (STAI-Y), Beck depression inventory (BDI-II), Hamilton depression rating scale (HDRS), well-being (WHO-5); anthropometric measures and body composition; Resting metabolic rate (RMR); blood pressure; serum levels of lipopolysaccharide (LPS), Zonulin, insulin, glucose, lipid profile (TG, HDL-C, LDL-C, TC), inflammatory biomarkers (IL-10, TNF-a, hs-CRP), and brain-derived neurotrophic factor (BDNF)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100209003320N15
Registration date:2018-08-02, 1397/05/11
Registration timing:registered_while_recruiting
Last update:2018-08-02, 1397/05/11
Update count:1
Registration date
2018-08-02, 1397/05/11
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of a weight loss diet with or without prebiotic supplementation on anthropometric measures, metabolic and inflammatory status, gut permeability, endotoxemia and depression status in obese women with major depression disorder
Public title
Effects of prebiotic supplementation and calorie restriction in major depressive disorder
Purpose
Treatment
Inclusion/Exclusion 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
willingness to participate in the study
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 type or dosage of any other medications or nutritional supplements, 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
Any significant events during the study, which might affect the patient's psychological health
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 48 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either prebiotic or placebo group, stratified by depression severity and BMI.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators (including the student, and her supervisor and adviser professors) as well as the patients will be blinded to the type of the supplement (prebiotic or placebo) received by each group. The person responsible for preparing the supplement sachets (who is completely unrelated to the study) will be asked to assign a three digit code to each of the two powders (prebiotic and placebo), and keep the codes for himself until the end of the study and data analyses.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/1573113
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.TBZMED.REC.1397.189
Health conditions studied
1
Description of health condition studied
Major depressive disorder, mild
ICD-10 code
F33.0
ICD-10 code description
Major depressive disorder, recurrent, mild
2
Description of health condition studied
Major depressive disorder, moderate
ICD-10 code
F33.1
ICD-10 code description
Major depressive disorder, recurrent, moderate
Primary outcomes
1
Description
Anthropometric measures
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumferences by a tape measure. Calculation of waist to hip ratio (WHR) by dividing waist circumference by hip circumference, and body mass index (BMI) by dividing weight (Kg) by height squared (m2)
2
Description
Body composition
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW)
3
Description
Resting metabolic rate
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Indirect calorimetry
4
Description
Gut permeability
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of Serum Zonulin by ELISA method
5
Description
Endotoxemia
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of serum lipopolysaccharide (LPS) by ELISA
6
Description
Blood pressure
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
stethoscope
7
Description
Blood glucose
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method
8
Description
Lipid profile
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation
9
Description
Inflammatory indices
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Measurement of serum hs-CRP by immunoturbidimetry, and serum TNF-a and IL-10 by ELISA
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 product by Sensus Co.and made in The Netherlands) which will be dissolved in a glass of water and used once a day with lunch.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive weight loss diet and placebo for 8 weeks.Placebo is a sachet containing 10 grams of maltodextrin (a product by FIC Co. and made in China)which will be dissolved in a glass of water and used once a day with lunch.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bozorghmehr Psychology Center, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Ranjbar
Street address
Across from Post Office, Artesh Jonoubi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138634348
Phone
+98 41 3540 3562
Email
fk_ranjbar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Vaghef-Mehrabany
Position
Ph.D. candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
elnaz.vaghef@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi Mamagani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
ebrahimimamagani@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Elnaz Vaghef-Mehrabany
Position
Ph.D. candidate in Nutritional Sciences
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences, Attar Neyshabouri Av., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
elnaz.vaghef@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
To access the required data, the researchers can contact Ms. Elnaz Vaghef-Mehrabany: email address: elnaz.vaghef@gmail.com cellphone number: 0098 9143044360
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of his Meta-analysis. His request will be assessed by the researchers, and if all of them agree to the request, the requested data will be emailed to the applicant in an Excel file format. All these procedures will take no longer than 15 days.