Protocol summary
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Study aim
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Objective: The aim of this study is to determine the effects of combined probiotic and selenium supplementation on metabolic profiles in patients with polycystic ovary syndrome.
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Design
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Study design: Randomized double-blind placebo-controlled trial. To decrease potential confounding effects, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Settings and conduct
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Among patients with polycystic ovary syndrome referred to Gynecology outpatient Clinic affiliated to Shahid Beheshti University of Medical Sciences, 60 patients will be selected according to inclusion and exclusion criteria. Participants, investigators or the assessors of the outcomes are unaware of the study groups. Supplements and placebos are similar in shape and size. Fasting blood samples will be taken at baseline and 12 weeks after the intervention. At the beginning and the end of the intervention: 12 weeks.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with polycystic ovary syndrome aged 18 to 40 years. Exclusion criteria: Women aged<18 or >40 years, individuals with neoplastic, hepatic, renal or CVD, malabsorptive disorders, current or previous (within the last 6 months) use of antidiabetic, or anti-obesity medications, pregnant women, taking selenium, probiotics and synbiotics supplements within the past 3 months.
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Intervention groups
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Intervention: Patients will be assigned into two groups to receive combined probiotic and selenium supplements (n=30) or placebo (n=30). Supplements and placebos are similar in shape and size.
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Main outcome variables
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Outcomes: Markers of insulin metabolism (primary outcomes) and lipid profiles (secondary outcome) will be quantified at study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017082733941N11
Registration date:
2017-10-02, 1396/07/10
Registration timing:
retrospective
Last update:
2019-09-15, 1398/06/24
Update count:
1
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Registration date
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2017-10-02, 1396/07/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2017-07-26, 1396/05/04
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Expected recruitment end date
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2017-08-02, 1396/05/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on metabolic profiles in women with polycystic ovary syndrome
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Public title
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Effect of combined probiotic and selenium supplementation in treatment of women with polycystic ovary syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with polycystic ovary syndrome aged 18 to 40 years
Exclusion criteria:
Women aged<18 or >40 years
Individuals with neoplastic, hepatic, renal or CVD, malabsorptive disorders, current or previous (within the last 6 months)
Use of antidiabetic, or anti-obesity medications
Pregnant women
Taking selenium, probiotics and synbiotics supplements within the past 3 months
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Age
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From 18 years old to 40 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To decrease potential confounding effects, after balanced blocked randomisation, all participants will be allocated into two treatment groups to take either supplements or placebo. Randomization will be done by the use of computer software.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-07-25, 1396/05/03
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Ethics committee reference number
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IR.SBMU.REC.1396.309
Health conditions studied
1
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Description of health condition studied
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Polycystic ovary syndrome
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ICD-10 code
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E28.2
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ICD-10 code description
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Polycystic ovarian syndrome
Primary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Elisa kit
2
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
Secondary outcomes
1
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Description
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Total cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
2
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Description
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HDL
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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FPG
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
Intervention groups
1
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Description
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Intervention group: Combined probiotic, including 2×109 Lactobacillus acidophilus, 2×109 Bifidobacterium bifidum, 2×109 Lactobacillus reuteri, 2×109 Lactobacillus fermentum daily, and selenium supplements (Webber Naturals, Mississauga, Canada), 200 µg, daily, for 12 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule (Barij Essence, Kashan, Iran), daily for 12 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available