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Protocol summary
Inclusion criteria: 1. Having at least 3 metabolic syndrome criteria 2. Age range 18-65 years 3. Willingness to cooperate 4. suffering schizophrenia for at least 1 year 5.BMI≥23
6. Disease of schizophrenia according to DSM-V criteria
Inclusion criteria: 1. Endocrine disorders 2. Weight loss medications, Corticosteroids over 10 days 3. History of weight loss surgeries 4. Any conditions that the researcher does not consider appropriate for the study 5. Drug abuse 6. Immune deficiency 7. Pregnant and lactating mothers and women of childbearing age 8. Female participants who plan to become pregnant 9. Change in dosage and type of medication at least 2 months prior to intervention 10. Antibiotic use from 1 month before study 11. Consumption Foods containing symbiotic, prebiotic and probiotic 1 month before intervention
Inclusion criteria: 1. Having at least 2 metabolic syndrome criteria 2. Age range 18-65 years 3. Willingness to cooperate 4. suffering schizophrenia for at least 1 year 5.BMI≥23
6. Disease of schizophrenia according to DSM-V criteria
Inclusion criteria: 1. Endocrine disorders 2. Weight loss medications, Corticosteroids over 10 days 3. History of weight loss surgeries 4. Any conditions that the researcher does not consider appropriate for the study 5. Drug abuse 6. Immune deficiency 7. Pregnant and lactating mothers and women of childbearing age 8. Female participants who plan to become pregnant 9. Change in dosage and type of medication at least 2 months prior to intervention 10. Antibiotic use from 1 month before study 11. Consumption Foods containing symbiotic, prebiotic and probiotic 1 month before intervention
Inclusion criteria: 1. Having at least 32 metabolic syndrome criteria 2. Age range 18-65 years 3. Willingness to cooperate 4. suffering schizophrenia for at least 1 year 5.BMI≥23 6. Disease of schizophrenia according to DSM-V criteria Inclusion criteria: 1. Endocrine disorders 2. Weight loss medications, Corticosteroids over 10 days 3. History of weight loss surgeries 4. Any conditions that the researcher does not consider appropriate for the study 5. Drug abuse 6. Immune deficiency 7. Pregnant and lactating mothers and women of childbearing age 8. Female participants who plan to become pregnant 9. Change in dosage and type of medication at least 2 months prior to intervention 10. Antibiotic use from 1 month before study 11. Consumption Foods containing symbiotic, prebiotic and probiotic 1 month before intervention
معیار ورود : 1. دارابودن حداقل 3معیار سندروم متابولیک2. محدوده سنی 18- 65 سال 3.تمایل به همکاری 4. مبتلا به اسکیزوفرنی حداقل به مدت 1 سال 5. BMI≥23.
6.ابتلا به اسکیزوفرنی طبق معیار DSM- V
معيارعدم ورود: 1. اختلالات اندوکرین 2.مصرف داروهای کاهش وزن ، کورتیکواستروئیدها بیش از 10 روز 3. سابقه جراحی های کاهش وزن 4. هر شرایطی که طبق آن محقق بیمار را مناسب شرکت در مطالعه نداند 5. سوء مصرف مواد 6. نقص سیستم ایمنی 7. مادر باردار و شیرده و زنان سنین باروری 8. شرکت کنندگان زن که قصد بارداری دارند 9. تغییر دوز و نوع داروی مصرفی حداقل 2 ماه قبل از شروع مداخله 10. مصرف آنتی بیوتیک از 1 ماه قبل از شروع مطالعه 11. مصرف مواد غذایی حاوی سین بیوتیک ، پره بیوتیک و پروبیوتیک 1 ماه قبل از شروع مداخله
معیار ورود : 1. دارابودن حداقل 2معیار سندروم متابولیک2. محدوده سنی 18- 65 سال 3.تمایل به همکاری 4. مبتلا به اسکیزوفرنی حداقل به مدت 1 سال 5. BMI≥23.
6.ابتلا به اسکیزوفرنی طبق معیار DSM- V
معيارعدم ورود: 1. اختلالات اندوکرین 2.مصرف داروهای کاهش وزن ، کورتیکواستروئیدها بیش از 10 روز 3. سابقه جراحی های کاهش وزن 4. هر شرایطی که طبق آن محقق بیمار را مناسب شرکت در مطالعه نداند 5. سوء مصرف مواد 6. نقص سیستم ایمنی 7. مادر باردار و شیرده و زنان سنین باروری 8. شرکت کنندگان زن که قصد بارداری دارند 9. تغییر دوز و نوع داروی مصرفی حداقل 2 ماه قبل از شروع مداخله 10. مصرف آنتی بیوتیک از 1 ماه قبل از شروع مطالعه 11. مصرف مواد غذایی حاوی سین بیوتیک ، پره بیوتیک و پروبیوتیک 1 ماه قبل از شروع مداخله
معیار ورود : 1. دارابودن حداقل 3معیار2معیار سندروم متابولیک2. محدوده سنی 18- 65 سال 3.تمایل به همکاری 4. مبتلا به اسکیزوفرنی حداقل به مدت 1 سال 5. BMI≥23. 6.ابتلا به اسکیزوفرنی طبق معیار DSM- V معيارعدم ورود: 1. اختلالات اندوکرین 2.مصرف داروهای کاهش وزن ، کورتیکواستروئیدها بیش از 10 روز 3. سابقه جراحی های کاهش وزن 4. هر شرایطی که طبق آن محقق بیمار را مناسب شرکت در مطالعه نداند 5. سوء مصرف مواد 6. نقص سیستم ایمنی 7. مادر باردار و شیرده و زنان سنین باروری 8. شرکت کنندگان زن که قصد بارداری دارند 9. تغییر دوز و نوع داروی مصرفی حداقل 2 ماه قبل از شروع مداخله 10. مصرف آنتی بیوتیک از 1 ماه قبل از شروع مطالعه 11. مصرف مواد غذایی حاوی سین بیوتیک ، پره بیوتیک و پروبیوتیک 1 ماه قبل از شروع مداخله
Protocol summary
Study aim
The Effect of Symbiotic Supplementation on the Components of Metabolic Syndrome in Schizophrenia Patients
Design
A randomized, double-blind, parallel design trial with one intervention and one control group
Settings and conduct
After obtaining consent, patients were randomly divided into two groups: taking symbiotic supplements (1 g daily) and controls (placebo with similar specifications). Patients receive supplementation for 8 weeks. Placebo and supplements are coded by someone other than the researcher. Participants and the lead researcher will not be informed of supplement and placebo content. At the beginning and end of the study, 10 cc blood samples will be taken to measure biochemical factors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Having at least 2 metabolic syndrome criteria 2. Age range 18-65 years 3. Willingness to cooperate 4. suffering schizophrenia for at least 1 year 5.BMI≥23
6. Disease of schizophrenia according to DSM-V criteria
Inclusion criteria: 1. Endocrine disorders 2. Weight loss medications, Corticosteroids over 10 days 3. History of weight loss surgeries 4. Any conditions that the researcher does not consider appropriate for the study 5. Drug abuse 6. Immune deficiency 7. Pregnant and lactating mothers and women of childbearing age 8. Female participants who plan to become pregnant 9. Change in dosage and type of medication at least 2 months prior to intervention 10. Antibiotic use from 1 month before study 11. Consumption Foods containing symbiotic, prebiotic and probiotic 1 month before intervention
Intervention groups
70 people with schizophrenia will be included in the study according to inclusion criteria. Subjects were randomly divided into two intervention groups (probiotic or placebo)
Main outcome variables
Waist circumference, fasting blood sugar, total cholesterol, high density lipoprotein, triglyceride, hypertension
General information
Reason for update
Two inclusion criteria were corrected because they could not affect the study outcomes. (PANSS and duration of the disease)
Acronym
IRCT registration information
IRCT registration number:IRCT20090901002394N45
Registration date:2019-12-26, 1398/10/05
Registration timing:registered_while_recruiting
Last update:2023-10-15, 1402/07/23
Update count:2
Registration date
2019-12-26, 1398/10/05
Registrant information
Name
Shima Jazayeri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8670 4805
Email address
sjazayeri@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia
Public title
Effects of Synbiotics on the Components of Metabolic Syndrome in Patients with Schizophrenia
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to collaborate
Complete the informed consent form by the patient and the patient's guardian
Age range 18-65 years
Schizophrenia according to DSM-V criteria (By a psychiatrist)
Outpatient
Duration of illness more than one year
BMI ≥ 23
Exclusion criteria:
Pregnancy and lactation
A history of drug or alcohol dependence or abuse
Diagnosis of mental retardation
Diagnosis of neurological disease or any serious illness that needs treatment
Diagnosis of major gastrointestinal, renal, heart, cancer, HIV infection or other immunodeficiency problems
Having a history of traumatic brain injury, seizures, epilepsy, Loss of consciousness (LOC) for more than 30 minutes, or other known neurological or organic diseases of the central nervous system
Having suicidal or homicidal thoughts or any safety concern by research staff
Sensitivity to probiotics, prebiotic and synbiotic
Subjects who may require imminent hospitalization
Change the Dose and type of medication used during the last 2 months
Receive of electricity shock treatment, immunosuppressive medications, stimulants, mood stabilizer during the last 3 months
Receive of Antibiotics in the last month
Consumption of Food or supplements containing probiotics, prebiotic and synbiotic over the last month such as kefir-yogurt-cheese and ...
Consumption of dietary supplements in the last month
Any disease or condition in which the researcher does not consider the participants appropriate for the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups receiving two daily synbiotic capsules or placebo after coding using random codes. Random allocation will be performed using four blocks classified by BMI and gender.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to double-blind the study of total cans containing capsules by a person other than the researcher, they will be divided into two groups in order to observe the researcher not knowing the type of capsules received by each group. Researcher, statistical consultant, and physician unaware of this classification This classification will be based on a random number table
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Iran University of Medical Sciences
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.IUMS.REC.1398.650
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Waist circumference
Timepoint
8 weeks
Method of measurement
Tape measure
2
Description
Fasting blood sugar
Timepoint
8 weeks
Method of measurement
Enzymatic colorimetric
3
Description
Total cholesterol
Timepoint
8 weeks
Method of measurement
Enzymatic colorimetric
4
Description
HDL
Timepoint
8 weeks
Method of measurement
Enzymatic colorimetric
5
Description
TG
Timepoint
8 weeks
Method of measurement
Enzymatic colorimetric
6
Description
blood pressure
Timepoint
8 weeks
Method of measurement
Mercury barometer
Secondary outcomes
1
Description
LDL
Timepoint
8 weeks
Method of measurement
Enzymatic colorimetric
2
Description
Serum insulin
Timepoint
8 weeks
Method of measurement
Eliza
3
Description
HOMA-IR
Timepoint
8 weeks
Method of measurement
Calculation by formula
4
Description
QUICKI
Timepoint
8 weeks
Method of measurement
Calculation by formula
5
Description
HbA1c
Timepoint
8 weeks
Method of measurement
analyzer
6
Description
hs-CRP
Timepoint
8 weeks
Method of measurement
Eliza
7
Description
Weight
Timepoint
8 weeks
Method of measurement
Standard scales
8
Description
BMI
Timepoint
8 weeks
Method of measurement
Calculation measured by height and weight
Intervention groups
1
Description
Intervention group: 2 capsules of 500mg Lactocare daily for 8weeks
Category
Treatment - Other
2
Description
Control group: Take 2 placebo capsules daily for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Psychiatric Hospital
Full name of responsible person
Dr. Fatemeh Hadi
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
samanbasafa82@rocketmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevallian
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian@iums.ac.ir
Grant name
Grant code / Reference number
100%
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Poorya Basafaroodi
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
samanbasafa82@rocketmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Shima Jazayeri
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
sh_jazayeri@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poorya Basafaroodi
Position
Master student in nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4805
Email
samanbasafa82@rocketmail.com
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 more information
Study Protocol
No - There is not 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
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
There is no more information
When the data will become available and for how long
There is no more information
To whom data/document is available
There is no more information
Under which criteria data/document could be used
There is no more information
From where data/document is obtainable
There is no more information
What processes are involved for a request to access data/document