Protocol summary
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Study aim
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The effect of Synbiotic Supplementation on the severity of different types of self-reported aggression and anger in healthy adult men.
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Design
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Randomization is done in the form of random blocks of volume 4. This study is in the third phase of the clinical trial.
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Settings and conduct
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The present study is a double-blind randomized clinical trial for 8 weeks in healthy adult men aged 18 to 75 years working at Iran University of Medical Sciences. None of the subjects studied, as well as the researcher and colleagues, will be aware of the group in which they are located and the type of intervention received.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Willingness to cooperate.
2- Age 18 to 75 years.
3- Having physical health and no history of cardiovascular diseases and etc.
4- No record of other mental illnesses.
5- Not taking certain medications in the past two months.
6- Not taking any omega-3, multivitamin-mineral supplements for at least the past two months.
7- Absence of severe family conflicts in the past 3 months.
Exclusion criteria:
1- The dissatisfaction to continue cooperation.
2- Consume probiotic-containing foods two weeks before and during the study.
3. Antibiotic use during the study.
4. Severe family conflicts during the study.
5- Consume less than 80% of supplements.
6- Occurrence of any disease during the intervention.
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Intervention groups
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Intervention group: 2 capsules of Femtactic Synbiotic daily.
Control group: 2 starch capsules daily.
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Main outcome variables
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self-reported aggression and anger.
General information
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Reason for update
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Due to the Corona epidemic and the opposition of the Department of Education, the project could not be implemented for 12- to 18-year-olds. Therefore, the target group of the study was changed to healthy adults (male employees of Iran University of Medical Sciences).
According to the change of title, diagnosis of aggression and externalizing behavior problems through the interview by a psychiatrist (according to DSM-5 criteria), Child Behavior Checklist (CBCL), Youth Self-Report (YSR) and Adolescent Physical Activity Questionnaire (PAQ-A) ), Which is for people under 18, have been removed. The Spielberger Anger Questionnaire was used to measure anger and the DASS-21 questionnaire was added to measure the severity of depression, stress and anxiety as a confounding factor. The International Physical Activity Questionnaire (IPAQ) was used to assess the level of physical activity.
The sample size varied according to similar studies in adults.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20091114002709N53
Registration date:
2020-02-22, 1398/12/03
Registration timing:
prospective
Last update:
2021-09-11, 1400/06/20
Update count:
1
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Registration date
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2020-02-22, 1398/12/03
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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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2021-09-23, 1400/07/01
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Expected recruitment end date
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2022-09-21, 1401/06/30
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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 effect of Synbiotic supplementation on the severity of different types of self-reported aggression and anger in healthy adult men.
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Public title
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The effect of Synbiotic on aggression
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Willingness to cooperate
18 to 75 years old
Having physical health and no history of cardiovascular, gastrointestinal, metabolic, autoimmune disease, allergies, etc.
No history of mental disease such as epilepsy, Bulimia nervosa, Anorexia, etc.
No anti-depressant, anti-inflammatory, anti-obesity, anti-diabetic medications, and hormone therapy for at least two months ago.
Not taking any omega-3, multivitamin-mineral supplements for at least two months ago.
lack of severe family conflicts in 3 months ago.
Exclusion criteria:
The dissatisfaction to continue cooperation.
Probiotic-containing foods consumption two weeks before and during the study.
Antibiotic consumption during the study.
Severe family conflicts during the study.
consuming Less than 80% of supplements delivered to adolescents.
Incidence of any disease during the study.
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Age
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From 18 years old to 75 years old
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Gender
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Male
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
100
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization is done in a randomized, stratified method based on the age and BMI. A randomized list of 100 capsules with codes A and B (randomized blocks of volume 4) is produced by the research consultant and is provided by the researcher.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Study subjects and researchers will be blinded to the intervention. Synbiotic and placebo capsules are similar in appearance, odor, weight and packaging and only the code on the package (A or B) is different.
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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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2019-09-30, 1398/07/08
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Ethics committee reference number
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IR.IUMS.REC.1398.694
Health conditions studied
1
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Description of health condition studied
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aggression
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ICD-10 code
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ICD-10 code description
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2
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Description of health condition studied
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anger
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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anger from Aggression Questionnaire
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Aggression Questionnaire
Secondary outcomes
1
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Description
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Aggression
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Timepoint
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Before the intervention and 2 months after the intervention
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Method of measurement
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Aggression Questionnaire
Intervention groups
1
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Description
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Intervention group: intake of two daily synbiotic of Familact capsule (produced by Bio-Fermentation Company) for 2 months, each capsule being 500 mg containing 7 species of Lactobacillus casei, Lactobacillus acidophilus , Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, Streptococcus thermophilus (109 CFU per capsule) with prebiotic fructooligosaccharide (38 mg).
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Category
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Treatment - Drugs
2
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Description
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Control group: Intake of 2 Caps daily containing 500 mg of 75% starch.
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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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Iran 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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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Some of the data will be shared, such as information about the main consequences and etc.
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When the data will become available and for how long
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The access period will be 6 months after publication of the results.
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To whom data/document is available
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The obtained data from the current study will be available only for researchers working in academic and scientific institutions.
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Under which criteria data/document could be used
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Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis.
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From where data/document is obtainable
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Applicants can be contacted with the corresponding author by e-mail or postal address to receive the requested data. Postal address: Nutrition department, School of Health, Iran University of Medical Sciences, Hemmat expressway, Tehran Phone number:0098 21 8862 2755
E-mail: Farzadshidfar@yahoo.com
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What processes are involved for a request to access data/document
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Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week.
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Comments
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