IRCT | The effects of synbiotic supplement containing Bacillus coagulans on glycemic control, lipid profile, testosterone, systemic inflammation and anthropometric measurements in women with polycystic ovarian syndrome.

Protocol summary

Study aim: determining the effects of synbiotic supplement containing Bacillus coagulans on glycemic control, lipid profile, testosterone, inflammation and anthropometric measurements in women with polycystic ovarian syndrome (PCOS).
Design: Two arm parallel group randomised trial, triple blind, phase 3 and on 50 women with PCOS. For randomization, the Stratified Blocked Randomization method will be used.
Settings and conduct: Individuals with polycystic ovary syndrome referred to the PCO clinic of Taleghani Hospital who meet the inclusion criteria will enter the study after obtaining written consent. Patients are then randomly assigned to the synbiotic supplement group and the placebo group for 12 weeks. At the beginning and end of the intervention, 5 cc of blood is taken from the participating patients after 10 to 12 hours of fasting and the patients' anthropometric indices are measured. Before the intervention, sachets containing synbiotic or placebo supplements are coded by the factory as A and B so that the blinding of the researcher, statistical analyst and patients about the type of supplements received by each group is observed.
Participants/Inclusion and exclusion criteria: Inclusion criteria: People with PCOS according to Rotterdam criteria, age between 18 to 45 years and at least 2 weeks after diagnosis and treatment. Exclusion criteria: Inflammatory, liver, kidney disease and use of antibiotics in the past three months.
Intervention groups: Patients will be randomly divided into synbiotic (n=25) and control (n=25) groups and will receive a synbiotic sachet containing Bacillus coagulans or a similar sachet containing placebo for 12 weeks, respectively.
Main outcome variables: Fasting blood sugar, Serum insulin, Hemostatic model of insulin resistance and pancreatic β cell function (HOMA-IR and HOMA-β, respectively), Quantitative insulin sensitivity check index and Serum total testosterone

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20150815023617N6

Registration date: 2022-06-22, 1401/04/01

Registration timing: registered_while_recruiting

Last update: 2022-06-22, 1401/04/01

Update count: 0
Registration date: 2022-06-22, 1401/04/01

Registrant information: Name

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 22077424

Email address

golbonsohrab@sbmu.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-06-22, 1401/04/01
Expected recruitment end date: 2023-03-18, 1401/12/27
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effects of synbiotic supplement containing Bacillus coagulans on glycemic control, lipid profile, testosterone, systemic inflammation and anthropometric measurements in women with polycystic ovarian syndrome.

Public title: The effects of synbiotic supplement containing Bacillus coagulans on women with polycystic ovarian syndrome.
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Having polycystic ovary syndrome according to Rotterdam criteria At least 2 weeks after the diagnosis and treatment of PCOS Being in the age range of 18-45 years Being in the BMI range: 18.5-35 Willingness to cooperate

Exclusion criteria:

Being pregnant Having liver disease, Kidney failure and heart failure, Infectious or inflammatory diseases, Thyroid disorders, Diabetes, Cancers, Hyperprolactinemia Take supplements or products containing synbiotics or probiotics in the past month Taking antibiotics in the last three months Consumption of corticosteroids or omega-3
Age: From 18 years old to 45 years old
Gender: Female

Phase

3

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 50

Randomization (investigator's opinion)

Randomized

Randomization description

For randomization of women, the Stratified Blocked Randomization method based on BMI, use of hormonal drugs that modulate the menstrual cycle and metformin will be used.

Blinding (investigator's opinion)

Triple blinded

Blinding description

In order to perform this research in a three blinded method, at the beginning of the study, the sachets containing synbiotic or placebo supplements are coded by the factory as A and B so that the lack of information of the researcher, statistical analyst and patients of the type of supplements received by each group is observed. .

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of National Nutrition & Food Technology Research Institute

Street address

No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town.

City

Tehran

Province

Tehran

Postal code

1998743664
Approval date: 2022-02-21, 1400/12/02
Ethics committee reference number: IR.SBMU.NNFTRI.REC.1401.017

Health conditions studied

1

Description of health condition studied: Polycystic Ovarian Syndrome
ICD-10 code: E28.2
ICD-10 code description: Polycystic ovarian syndrome

Primary outcomes

1

Description: Fasting blood glucose (FBG)
Timepoint: Measurement of fasting blood sugar at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Enzymatic method

2

Description: Serum Insulin
Timepoint: Measurement of serum insulin at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Elisa method

3

Description: Serum total testosterone
Timepoint: Measurement of serum total testosterone at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Elisa method

4

Description: HOMA-β: The homeostasis model assessment of pancreatic β-cell function
Timepoint: Measurement of HOMA-β at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Calculating by formula: HOMA-β=360×Insulin (lnternational Unit/mililiter)/Fasting glucose (miligram/deciliter) − 63

5

Description: HOMA-IR: Homeostatic model assessment of insulin resistance
Timepoint: Measurement of HOMA-IR at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Calculating by formula: HOMA-IR = [FBG (miligram/deciliter)×Fasting Insulin (lnternational Unit/mililiter)]/405.

6

Description: QUICKI: The quantitative insulin-sensitivity check index
Timepoint: Measurement of QUICKI at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Calculating by formula: QUICKI = 1/[log fasting insulin (lnternational Unit/mililiter)+log fasting glucose(miligram/deciliter)]

Secondary outcomes

1

Description: Serum triglyceride (TG)
Timepoint: Measurement of serum triglyceride at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Enzymatic method

2

Description: Serum total cholesterol
Timepoint: Measurement of serum total cholesterol at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Enzymatic method

3

Description: Low density lipoprotein cholestrol (LDL-C)
Timepoint: Measurement of low density lipoprotein cholestrol (LDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Enzymatic method

4

Description: High density lipoprotein cholestrol (HDL-C)
Timepoint: Measurement of high density lipoprotein cholestrol (HDL-C) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Enzymatic method.

5

Description: C reactive protein quantitive (CRP Quantitive)
Timepoint: Measurement of C reactive protein quantitive (CRP Quantitive) at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Elisa method

6

Description: Weight
Timepoint: Measurement of weight at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Body weight scale

7

Description: waist circumference
Timepoint: Measurement of waist circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Tape meter

8

Description: Hip circumference
Timepoint: Measurement of hip circumference at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Tape meter

9

Description: Body mass index
Timepoint: Measurement of BMI at the beginning of the study (before the intervention) and 90 days after the start of synbiotic consumption.
Method of measurement: Calculating by formula: Weight in kilogram / the square of the height in centimeters

Intervention groups

1

Description: Intervention group: For 12 weeks, they will consume 1 sachet of synbiotic from Parsi Lact Co, Iran daily. Each 2 gram sachet contains 10 to the power of 10 CFU/g of Bacillus coagulans, 10 to the power of 10 CFU/g of Lactobacillus rhamnos, 10 to the power of 10 CFU/g of Lactobacillus helveticus, 500 mg of fructooligosaccharide and a 0.7% orange flavor.
Category: Treatment - Drugs

2

Description: Control group: For 12 weeks, they will consume 1 sachet of placebo from Parsi Lact Co, Iran daily. Each 2 gram sachet contains starch and a 0.7% orange flavor.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Women and PCOS Clinic of Ayatollah Taleghani Hospital

Full name of responsible person

Golbon Sohrab

Street address

Ayatollah Taleghani Hospital, Shahid A'arabi St., Shahid Chamran Highway, Yemen St., Tehran.

City

Tehran

Province

Tehran

Postal code

1985711151

Phone

+98 21 2303 1111

Fax

+98 21 2243 2570

Email

taleghanihospital@sbmu.ac.ir

Web page address

https://taleghani.sbmu.ac.ir

1

Sponsor: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Dr Morteza Abdolahi

Street address

No. 7, Shahid Hafezi St. (West Arghavan), Shahid Farahzadi Blvd, Qods Town.

City

Tehran

Province

Tehran

Postal code

1981619573

Phone

+98 21 2208 6349

Email

golbonsohrab@sbmu.ac.ir

Web page address

https://nutrition.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shahid Beheshti 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

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Golbon Sohrab

Position

َAssistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1981619573

Phone

+98 21 2235 7483

Email

golbonsohrab@sbmu.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Golbon Sohrab

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

No. 7, West Hafezi Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1981619573

Phone

+98 21 2207 7425

Email

golbonsohrab@sbmu.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shahid Beheshti University of Medical Sciences

Full name of responsible person

Golbon Sohrab

Position

Assistant professor

Latest degree

Ph.D.

Other areas of specialty/work

Nutrition

Street address

No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town

City

Tehran

Province

Tehran

Postal code

1981619573

Phone

+98 21 2207 7425

Email

golbonsohrab@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Yes - There is a plan to make this available
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Yes - There is a plan to make this available
Title and more details about the data/document: Only part of the data is shared, such as the original outcome.
When the data will become available and for how long: The start of the access period is 12 months after printing the results.
To whom data/document is available: It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used: The documentation can only be used for more complete studies in this field.
From where data/document is obtainable: Dr Golbon Sohrab Faculty member (assistant professor) at Faculty of Nutrition Sciences & Food Technology, Shaheed Beheshti University of Medical Sciences Email: golbonsohrab@sbmu.ac.ir
What processes are involved for a request to access data/document: The communication will be possible through the electronic mail given in the previous section.
Comments

The effects of synbiotic supplement containing Bacillus coagulans on glycemic control, lipid profile, testosterone, systemic inflammation and anthropometric measurements in women with polycystic ovarian syndrome.