Protocol summary
-
Study aim
-
Evaluating effects of probiotic and magnesium co-supplementation on mood, intestinal barrier function and stool microbial populations in obese subjects with metabolic mood syndrome
-
Design
-
A two-arm, parallel double blind controlled randomized clinical trial
-
Settings and conduct
-
Recruitment will take place in Imama Reza Clinic, Shiraz,Iran. Two assessors will collect data and conduct random allocation according to the orders already provided by a statistician. Intervention and placebo capsules will be in same containers with labels "A" or"B" provided by a non involved faculty, so both subjects and assessors will be blinded to the intervention type.
-
Participants/Inclusion and exclusion criteria
-
men and women with age range of 18 to 50 years old willing to participate in the study, with Body Mass Index≥30 and waist circumference>=85cm and 102 cm in women and men, respectively. Beck Depression Inventory scores ranging from 17 to 40. No history of chronic diseases. Not using probiotics in the last 2 months, or antibiotic in the last 3 months. Pregnancy, breast feeding, menopause, regular smoking or alcohol use, addiction, regular intake of anti-inflammatory drugs and using magnesium, omega-3, and anti-oxidants in the previous month will also make subjects un-eligible for the study
Exclusion Criteria:
pregnancy, significant change in diet or physical activity, starting new drugs or antibiotics, and not intending to continue study protocols.
-
Intervention groups
-
One capsule containing probiotic species of Lactobacillus and Bifidobacteria + a capsule containing magnesium chloride. Control group will receive identical capsules containing maltodextrin
-
Main outcome variables
-
Glucose, insulin, insulin resistance markers,cortisol, Zonulin, Endotoxin, CRP, Beck,MoCA & DASS scores,, quality of life, stool population of Bacteroidetes, Firmicutes, Akkermensia Muciniphila,anthropometric measures
General information
-
Reason for update
-
After we reviewed the evidence and based on consultation with our statistician our team decided to decrease the intervention period from 12 to 9 weeks.
Furthermore, a number of outcome variables has been added to the previously recorded variables including: serum levels of cortisol, insulin, fasting glucose, C-reactive protein, as well as markers of insulin resistance (ًQUICKI,HOMAIR), DASS anexiety,stress and depression scores, Quality of life, and percent of fat-free mass and fat mass.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20191127045525N1
Registration date:
2020-04-07, 1399/01/19
Registration timing:
prospective
Last update:
2021-09-12, 1400/06/21
Update count:
1
-
Registration date
-
2020-04-07, 1399/01/19
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-04-20, 1399/02/01
-
Expected recruitment end date
-
2020-09-21, 1399/06/31
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Effects of co-supplementation with probiotic and magnesium on components of microbiota-gut-brain axis including mood, intestinal barrier function and stool microbial populations in obese subjects with metabolic mood syndrome
-
Public title
-
Probiotic applications in obesity and related mood disorders
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
ٌWilling to participate in the study
Age range of 18 to 50 years
Body Mass Index (BMI) ≥30 and waist circumference (WC) more than 85cm in women and 102 cm in men
Beck Depression Inventory (BDI) scores ranging between 17 to 40
Not taking probiotic supplements in the last 2 months and antibiotics in the last 3 months
Absence of chronic liver, kidney, cardiovascular, GI and infectious diseases as well as diabetes, and severe neurological and psychiatric disorders.
Not using anti-depressants
Not using antioxidants, omega-3 and magnesium supplements less than one month prior to study commencement
Not regular use of steroid and non-steroid anti-inflammatory drugs
No regular alcohol drinking or smoking, No opioid addiction
No history of heart attack, not being pregnant or intending pregnancy, not being in breastfeeding or menopausal states.
Exclusion criteria:
pregnancy, any significant change in diet or physical activity, starting new drugs or antibiotics, and not intending to continue study protocols.
-
Age
-
From 18 years old to 50 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
-
Sample size
-
Target sample size:
90
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
By implementing block randomization method using blocks of four, eligible subjects will be randomly allocated to either intervention or control group. Allocation concealment will be conducted by application of sealed envelopes containing active or placebo, created by a colleague that is not involved with data gathering and participant evaluation.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
All active capsules and placebo will be the same in size, color, odor, taste and other related characteristics. Furthermore, the packaging will be the same so neither data collectors and outcome assessors (that are the same in the present study) nor participants will be aware of the intervention type.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-03-03, 1398/12/13
-
Ethics committee reference number
-
IR.SUMS.REC.1398.1375
2
-
Ethics committee
-
-
Approval date
-
2020-05-30, 1399/03/10
-
Ethics committee reference number
-
IR.SUMS.REC.1399.212
Health conditions studied
1
-
Description of health condition studied
-
Obesity with mood disorders
-
ICD-10 code
-
E66.0
-
ICD-10 code description
-
Obesity due to excess calories
Primary outcomes
1
-
Description
-
Beck Depression Inventory (BDI) score
-
Timepoint
-
Before commencement and after 12 weeks of intervention
-
Method of measurement
-
Beck Depression Questionnaire
Secondary outcomes
1
-
Description
-
Beck Anxiety Inventory (BAI) score
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Beck anxiety questionnaire
2
-
Description
-
Plasma Zonulin Levels
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
ELIZA
3
-
Description
-
Plasma Endotoxin
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
ELIZA
4
-
Description
-
Some Stool Bacterial populations
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Real time PCR
5
-
Description
-
Waist
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Tape meter
6
-
Description
-
Weight
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Body analyzer (Inbody)
7
-
Description
-
Body mass index
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Body analyzer (Inbody)
8
-
Description
-
fat mass
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Body analyzer (Inbody)
9
-
Description
-
fat free mass
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Body analyzer (Inbody)
10
-
Description
-
Quality of life
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
qol-12 questionnaire
11
-
Description
-
depression . stress and anxiety scores
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
DASS anxiety, stress & depression questionnaire
12
-
Description
-
Fasting serum cortisol
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
ELIZA
13
-
Description
-
Fasting blood glucose
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Autoanalyzer
14
-
Description
-
Fasting serum insulin
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
ELIZA
15
-
Description
-
Homeostatic Model Assessment for Insulin Resistance (HOMAIR)
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
FORMULA
16
-
Description
-
quantitative insulin-sensitivity check index (QUICKI)
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
FORMULA
17
-
Description
-
C-reactive protein
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
ELIZA
18
-
Description
-
Serum magnesium
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Autoanalyzer
19
-
Description
-
Montreal Cognitive Assessment score (MoCA)
-
Timepoint
-
Before commencement and 9 weeks after intervention
-
Method of measurement
-
Questionnaire
Intervention groups
1
-
Description
-
Intervention group will recieve 1 gram Capsule containing lactobacillus and bifidobacteria at dose of 3*10 9 CFU + one capsule containing 1 gram magnesium chloride providing 250 milligrams of elemental magnesium on a daily basis after one of main meals (preferably dinner)
-
Category
-
Other
2
-
Description
-
Control group will receive two 1-gram capsules containing maldodextrin similar to those with active components based on color, shape, odor, weight, and packaging, on a daily basis after a main meal (preferably dinner).
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
Razi Festival
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shiraz University of Medical Sciences
-
Proportion provided by this source
-
60
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is no further information
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be 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