Protocol summary

Study aim
Determination and comparison of synbiotic supplementation effect on metabolic status, serum apelin levels and anthropometric profiles in patients with polycystic ovary syndrome
Design
Randomized, double-blind, placebo-controlled Population studied: Individuals with polycystic ovarian syndrome were randomly divided into 2 groups, group1 receiving synbiotic (1 capsule 500 mg),group 2 placebo group (1 capsule 500 mg placebo),Supplements will be provided for 8 weeks. Sample size: 68 people (2 groups of 34). Study Intervention: Synbiotic Supplement
Settings and conduct
The aim of this study was to evaluate the effect of synbiotic supplementation on metabolic status in patients with PCOS referring to women's specialized clinic in Tabriz. For each person, the general characteristics questionnaire, anthropometric evaluations,, Food registration and the International Assessment of Physical Activity (IPAQ) will be completed. To measure all biochemical parameters, 10 cc of venous blood is collected fast (at the beginning and end of the study) and their serum will be separated and kept until (70 °) until the tests are performed.
Participants/Inclusion and exclusion criteria
Entry criteria: Women aged 20-45 years and BMI Between 40-25, , PCOS diagnosis based on Rotterdam standard 2003 Exit criteria: history of thyroid disorders, ..., pregnancy and lactation, consumers of anti-obesity drugs ..., sensitivity to synbiotic and probiotic capsules,intake of probiotic , perebiotic, synbiotic in the last three months And during the study, regular consumption of probiotic products
Intervention groups
group1 receiving synbiotic (1 capsule 500 mg) group 2 placebo group (1 capsule 500 mg placebo)
Main outcome variables
The effect of synbiotic supplementation on metabolic status, serum apelin levels and anthropometric profiles

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100408003664N19
Registration date: 2018-03-18, 1396/12/27
Registration timing: prospective

Last update: 2018-03-18, 1396/12/27
Update count: 0
Registration date
2018-03-18, 1396/12/27
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of synbiotic supplementation on metabolic status ، serum apelin levels and anthropometric indexes in patients with polycystic ovary syndrome
Public title
Effect of synbiotic supplementation in patients with polycystic ovary syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
• Women with PCOS aged 20-40 years • Diagnosis of PCOS in patients by Gynecologist and according to Rotterdam Standard 2003• The BMI range is between 40-25 m ^ 2/ kg
Exclusion criteria:
• History of thyroid disorders, hyperprolactinemia, Cushing's syndrome, liver and kidney disease, cardiovascular disease, digestive diseases (food allergies, celiac disease, irritable bowel disease), high blood pressure and diabetes. Diagnosis of non-disease By asking the patient, using the existing tests and under the supervision of the doctor will be done. • Pregnancy and breastfeeding • Consumers of anti-obesity drugs and blood lipid lowering drugs, anticoagulants and glucocorticoids • Using a weight loss diet • smoking • Athlete or regular exercise • Sensitivity to synbiotic and probiotic capsules • Antibiotic use a month ago • Use of any dietary supplements in the last 2 months or during the study • Receiving probiotics, perebiotic, synbiotics during the last three months and during the study • Regular consumption of probiotic products
Age
From 20 years old to 44 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were selected using available methods and randomly assigned random blocks of 4 volumes to the study groups.A random sequence is generated using the STATA14 software.During the random assignment, individuals in the groups will be classified according to age and BMI variables
Blinding (investigator's opinion)
Double blinded
Blinding description
Double blind practices: Trials that are planned in a way that neither the studied subjects nor the observers (researchers) know who the group is.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.TBZMED.REC.1396.1080

Health conditions studied

1

Description of health condition studied
polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
Begining and end of the intervention
Method of measurement
Analysing With Spectrophotometer

2

Description
Level of Serum Insulin
Timepoint
Begining and end of the intervention
Method of measurement
Analysing with ELISA

3

Description
HOMA-IR
Timepoint
Begining and end of the intervention
Method of measurement
Calculated According to The Formula

4

Description
Total Cholestrol
Timepoint
Begining and end of the intervention
Method of measurement
Analysing With Spectrophotometer

5

Description
HDL-C
Timepoint
Begining and end of the intervention
Method of measurement
Analysing With Spectrophotometer

6

Description
LDL-C
Timepoint
Begining and end of the intervention
Method of measurement
Calculated According to The Friedewald Formula

7

Description
TG
Timepoint
Begining and end of the intervention
Method of measurement
Analysing With Spectrophotometer

Secondary outcomes

1

Description
Apelin
Timepoint
Beginning and end of intervention
Method of measurement
Analysing With ELISA

2

Description
anthropometric indexes
Timepoint
Beginning and end of intervention
Method of measurement
Measuring with scales and meters

Intervention groups

1

Description
Intervention group: En Interventions 1: 500mg capsules of synbiotic 1 per day for 8 weeks Interventions ,, Half an hour after lunch, the product of Biostimiran Company
Category
Treatment - Drugs

2

Description
Control group: Placebo: 500 mg capsule 1 per day for 8 weeks, half an hour after lunch
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al Zahra hospital
Full name of responsible person
Sima Darvishi
Street address
South Army Streets, Garden of the Nineh Cross
City
Tabriz
Province
East Azarbaijan
Postal code
5138663134
Phone
+98 41 3553 9161
Email
simaadarvishi@gmail.com
Web page address
http://blog.shafadoc.ir/tag/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Darvishi
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Email
simaadarvishi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Darvishi
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
simaadarvishi@gmail.com
Web page address
http://nutr.tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Darvishi
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Sience,Nutrition Faculty, Attar Neyshabori,Golgasht street,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Fax
+98 41 3334 0634
Email
simaadarvishi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sima Darvishi
Position
Master's Degree in Nutrition Sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science,Nutrition Faculty,Attar Neyshabori,Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
simaadarvishi@gmail.com
Web page address
http://nutr.tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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