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The Effect of Synbiotic Supplementation on 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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201608299856N3
Enrollment
132
Registered
2017-02-07
Start date
2016-10-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: 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. Intervention 2: for intervention group: Synbiotic Dietary Supplement, 500 mg capsule, twic
Additionally, training low calorie diet will be taught for this group in baseline and in the end of 6th week.
Placebo
Treatment - Drugs
for control group: Standardized Placebo, quite similar to synbiotic capsules, twice/day by oral , for 3 months
for intervention group: Synbiotic Dietary Supplement, 500 mg capsule, twice/day by oral, for 3 months

Sponsors

Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Sciences
Lead Sponsor
ZistTakhmir Pharmaceutical Company
Collaborator

Eligibility

Sex/Gender
All
Age
24 Years to 64 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
LDL-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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFateme Rahimi

Public Health faculty of Kermanshah University of Medical Sciences

f.rahimi@kums.ac.ir; yahya.pasdar@kums.ac.ir+98 83 3828 1991

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026