The aim of this study is to determine the effect of synbiotic supplement on the metabolic syndrome components in military personnel with this syndrome, Valiasr Hospital, Tehran. This study is a double blind Randomised clinical trial .
Sixty patients suffering from metabolic syndrome assigned randomly into two groups: 1- Sinobiotic supplementation group( one supplement / day for 8 weeks) (intervention group) 2- Placebo (control group). Before and after the intervention, weight, BMI, WC, FBS, HDL, TG and blood pressure will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age (20-50 years) and According to the definition by IDF: Military personnel have the metabolic syndrome if the following criteria is met:Central obesity: waist circumference ≥94 Cm in Men and ≥ 80 Cm in women, plus any two of the following four components:triglyceride level:≥ 150 mg/dl; HDL cholesterol:≤ 50 in men and ≤ 40 mg/dl in women; blood pressure: ≥ 130/85 mmHg; fasting plasma glucose: ≥ 100 mg/dl
Exclusion criteria
Having a history of cardiovascular disease, liver and kidney problems, alcohol and smoking, and postmenopausal women
Intervention groups
Patients with Metabolic Syndrome
Main outcome variables
Waist circumference; HDL; TG; FBS and blood pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140502017522N3
Registration date:2019-03-16, 1397/12/25
Registration timing:prospective
Last update:2019-03-16, 1397/12/25
Update count:0
Registration date
2019-03-16, 1397/12/25
Registrant information
Name
Maryam Taghdir
Name of organization / entity
Baqiyatallah University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 5511
Email address
mtaghdir@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplement on metabolic syndrome components in military personnel with this syndrome
Public title
The effect of synbiotic supplement on metabolic syndrome components in military personnel with this syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age (20-50 years) and According to the definition by IDF:
Military personnel have the metabolic syndrome if the following criteria is met:
Central obesity: waist circumference ≥94 Cm in Men and ≥ 80 Cm in women, plus any two of the following four components:
triglyceride level:≥ 150 mg/dl;
HDL cholesterol:≤ 50 in men and ≤ 40 mg/dl in women;
blood pressure: ≥ 130/85 mmHg;
fasting plasma glucose: ≥ 100 mg/dl.
Exclusion criteria:
Having a history of cardiovascular disease,
liver and kidney problems
alcohol and smoking,
postmenopausal women.
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 military personnel simple randomized to two groups A and B using the table of random numbers . Only the company knows the contents of the supplements and names the supplements as A and B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant and investigator
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical sciences,Bahae street, Mollasadrai Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.Bmsu.REC.1397.148
Health conditions studied
1
Description of health condition studied
Metabolic syndrome
ICD-10 code
(E00-E90)
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Body mass index(BMI)
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
Wt(Kg)/Ht(m2)
2
Description
Fasting blood sugar(FBS)
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
In mg / dl using an autoanalyzer device
3
Description
blood pressure(BP)
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
Using the blood pressure device in mm / hg
4
Description
HDL cholesterol
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
In mg / dl using auto-analyzer
5
Description
Tri glyceride
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
In mg / dl and using auto-analyzer
6
Description
Waist circumference
Timepoint
2 times: 1. Before supplementation 2. After 8 weeks
Method of measurement
Measured with meter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: one synbiotic capsule per day for 8 weeks.