Protocol summary
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Study aim
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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.
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Design
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Randomized double-blind clinical trial with two arm parallel groups
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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, MCP-1, TLR-4), and brain-derived neurotrophic factor (BDNF), tryptophan and Kynurenine
General information
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Reason for update
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Additional biomarkers will be assayed in the serum samples of the patients, as the assessed outcomes of two new Masters' theses. Information about these biomarkers as well as ethics codes for these theses are added to this project.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100209003320N15
Registration date:
2018-08-02, 1397/05/11
Registration timing:
registered_while_recruiting
Last update:
2019-11-26, 1398/09/05
Update count:
1
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Registration date
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2018-08-02, 1397/05/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-06-22, 1397/04/01
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Expected recruitment end date
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2018-09-22, 1397/06/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effects of prebiotic supplementation and calorie restriction in major depressive disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 50 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-05-21, 1397/02/31
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Ethics committee reference number
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IR.TBZMED.REC.1397.189
2
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Ethics committee
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Approval date
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2019-10-14, 1398/07/22
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Ethics committee reference number
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IR.TBZMED.REC.1398.718
3
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Ethics committee
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Approval date
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2019-11-11, 1398/08/20
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Ethics committee reference number
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IR.TBZMED.REC.1398.813
Health conditions studied
1
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Description of health condition studied
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Major depressive disorder, mild
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ICD-10 code
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F33.0
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ICD-10 code description
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Major depressive disorder, recurrent, mild
2
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Description of health condition studied
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Major depressive disorder, moderate
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ICD-10 code
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F33.1
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ICD-10 code description
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Major depressive disorder, recurrent, moderate
Primary outcomes
1
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Description
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Anthropometric measures
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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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
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Description
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Body composition
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Bioelectrical Impedance Analysis (BIA) to determine Fat mass (FM), Fat free mass (FFM), and Body water (BW)
3
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Description
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Resting metabolic rate
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Indirect calorimetry
4
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Description
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Gut permeability
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of Serum Zonulin by ELISA method
5
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Description
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Endotoxemia
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of serum lipopolysaccharide (LPS) by ELISA
6
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Description
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Blood pressure
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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stethoscope
7
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Description
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Blood glucose
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Enzymatic method
8
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Description
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Lipid profile
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of total cholesterol, HDL-cholesterol and triglyceride through enzymatic methods and calculation of LDL-cholesterol by Friedewald equation
9
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Description
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Inflammatory indices
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Measurement of serum hs-CRP by immunoturbidimetry, and serum TNF-a and IL-10 by ELISA
10
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Description
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State-trait anxiety
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Spielberger State-Trait Anxiety Inventory (STAI-Y)
11
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Description
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Depression severity
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Beck Depression Inventory (BDI-II)
12
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Description
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Depression remission
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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Hamilton Depression Rating Scale (HDRS)
13
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Description
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Psychological well-being
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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WHO-5 questionnaire
14
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Description
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Serum brain-derived neurotrophic factor (BDNF)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
15
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Description
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Serum Monocyte Chemoattractant Protein-1 (MCP-1)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
16
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Description
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Serum Toll-like receptor 4 (TLR_4)
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
17
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Description
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Serum Tryptophan
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
18
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Description
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Serum kynurenine
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Timepoint
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Baseline and 8 weeks after intervention
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Method of measurement
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ELISA
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Data collected for the primary outcomes will be shared.
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When the data will become available and for how long
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access starting 12 months after publication
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To whom data/document is available
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The data will only be available for people working in academic institutions.
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Under which criteria data/document could be used
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The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
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From where data/document is obtainable
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To access the required data, the researchers can contact Ms. Elnaz Vaghef-Mehrabany: email address: elnaz.vaghef@gmail.com cellphone number: 0098 9143044360
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What processes are involved for a request to access data/document
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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.
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Comments
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