Investigating the Effect of Synbiotic Supplementation and educating low-calorie diet on the Lipid Profile and the Gut Micro-flora in Patients with Metabolic Syndrome
Investigating the Effect of Synbiotic Supplementation and educating low-calorie diet on the Lipid Profile and the Gut Micro-flora in Patients with Metabolic Syndrome
The study will be conducted as a double-blind randomized controlled trial with the standard placebo. The required sample size for this study, considering the 20% probability of subject missing, will be 66 subjects for each groups and 132 subjects in total. All the subjects will be taught low-calorie diet, then subjects randomly will be divided into the two groups of receiving synbiotic or standard placebo. All of the procedures will be conducted double-blind to the researcher and patients alike and in supervision of a third person. The intervention will be done for 12 weeks. Regarding the results of previous human studies conducted on synbiotic, consumption of these capsules will not have any side effects for patients.
Patients who have at least 3 criteria of all of 5 criteria of Metabolic Syndrome provided that not taking medication for controlling Blood Glucose, Blood Lipid and Hypertension will be included into the study. In case of losing any of including criteria or having to taking any of mentioned medications, the patient will be excluded from the study.
The main outcomes expected to be affected by the interventions, will be include: dysbiosis modifying; increase in High-Density Lipoprotein-Cholesterol (HDL-C); decrease in Low-density Lipoprotein- Cholesterol (LDL), Triglycerides, Blood Pressure and Waist Circumference.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608299856N3
Registration date:2017-02-07, 1395/11/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-07, 1395/11/19
Registrant information
Name
Yahya Pasdar
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1828 1991
Email address
yahya.pasdar@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
1. Deputy of Research and Technology, Kermanshah University of Nedical Sciences
2. ZistTakhmir Pharmaceutical Company
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Synbiotic Supplementation and educating low-calorie diet on the Lipid Profile and the Gut Micro-flora in Patients with Metabolic Syndrome
Public title
The Effect of Synbiotic Supplementation on Metabolic Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling the consent form of the present project in the beginning of study; lack of any kinds of chronic diseases such as diabetes, renal diseases, tuberculosis, liver diseases and/or the history of cardiac surgeries; possessing at least 3 items of all the 5 indexes of metabolic syndrome (based on the definition by NCEP ATP III) (in case of insulin resistance, patients must have fasting blood glucose less than 126 mg/dL); lack of taking medication to control blood glucose, blood lipid and hypertension in the beginning of study ; the age range is between 25 to 65 year; lack of injecting/receiving insulin so as to blood glucose control in the beginning of study.
Exclusion criteria:
Lack of regular taking the given supplements; lack of following the given diet; starting taking medication or supplements that may be affect the results of test of investigated factors or oral contraceptives, estrogen, progesterone and corticosteroids; pregnancy; weaning, receiving insulin or tablet to control the blood glucose; losing any of inclusion criteria during the time of conducting the study.
Age
From 24 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences Ethics Committee
Street address
Deputy of Research and Technology, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Postal code
Approval date
2016-10-19, 1395/07/28
Ethics committee reference number
kums.rec.1395.467
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15.9
ICD-10 code description
Secondary hypertension, unspecified
2
Description of health condition studied
Hyperglyceridaemia
ICD-10 code
E78.1
ICD-10 code description
Pure hyperglyceridaemia
3
Description of health condition studied
High-density lipoprotein deficiency
ICD-10 code
E78.6
ICD-10 code description
Lipoprotein deficiency
Primary outcomes
1
Description
blood pressure
Timepoint
base line, at the end of 6th week and aftar 3 months of begin
Method of measurement
in term of mm Hg by Mercury barometers
2
Description
plasma HDL-C
Timepoint
base line and aftar 3 months of begin
Method of measurement
in term of mg/ dL by biochemical kits
3
Description
plasma TG
Timepoint
base line and aftar 3 months of begin
Method of measurement
in term of mg/ dL by biochemical kits
4
Description
Waist Circumference
Timepoint
base line, at the end of 6th week and aftar 3 months of begin
Method of measurement
in term of centimeter by Tape measure
Secondary outcomes
1
Description
LDL-C
Timepoint
baseline and after 3th month
Method of measurement
in term of mg/ dL, by using biochemical kits
2
Description
Total Cholesterol
Timepoint
baseline and after 3th month
Method of measurement
in term of mg/ dL, by using biochemical kits
3
Description
Body Fat Mass
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg, by usig body analyzer instrument
4
Description
Body Fat Free Mass
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg, by usig body analyser instrument
5
Description
Body Mass Index (BMI)
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg/ m2
6
Description
weight
Timepoint
baseline, at the end of 6th week and after 3th month
Method of measurement
in term of kg by using standardized scale
Intervention groups
1
Description
for control group: Standardized Placebo, quite similar to synbiotic capsules, twice/day by oral , for 3 months; Additionally, training low calorie diet will be taught for this group in baseline and in the end of 6th week.
Category
Placebo
2
Description
for intervention group: Synbiotic Dietary Supplement, 500 mg capsule, twice/day by oral, for 3 months; Additionally, training low calorie diet will be taught for this group in baseline and in the end of 6th week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Administration of Education
Full name of responsible person
Ms.Nazari
Street address
Phase1, Farhangian, next to the Moalem Park
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences
Full name of responsible person
Kourosh Hamzehee
Street address
Vice– Chancellery of Research & Technology Affairs, Building No. 2 of Kermanshah University of Medical Sciences, Naft Square, Shahid Beheshti blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences