The Effect of Synbiotic Supplementation on Metabolic Syndrome

Phase 2

• Conditions: Condition 1: Hypertension. Condition 2: Hyperglyceridaemia. Condition 3: High-density lipoprotein deficiency.; Secondary hypertension, unspecified; Pure hyperglyceridaemia; Lipoprotein deficiency

• Registration Number: IRCT201608299856N3
• Lead Sponsor: Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 132

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Plasma HDL-C. Timepoint: base line and aftar 3 months of begin. Method of measurement: in term of mg/ dL by biochemical kits.;Plasma TG. Timepoint: base line and aftar 3 months of begin. Method of measurement: in term of mg/ dL by biochemical kits.;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 Outcome Measures

Name	Time	Method
DL-C. Timepoint: baseline and after 3th month. Method of measurement: in term of mg/ dL, by using biochemical kits.;Total Cholesterol. Timepoint: baseline and after 3th month. Method of measurement: in term of mg/ dL, by using biochemical kits.;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.;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.;Body Mass Index (BMI). Timepoint: baseline, at the end of 6th week and after 3th month. Method of measurement: in term of kg/ m2.;Weight. Timepoint: baseline, at the end of 6th week and after 3th month. Method of measurement: in term of kg by using standardized scale.