Surrvey the effect of Probiotic Supplement on antropometric indexes, hormonal and metabolic parameters, clinical symptoms and serum apelin level in women with polycystic ovary syndrom
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Objectives: Determine the effect of probiotic supplementation on antropometric indexes, hormonal and metabolic parameters, clinical symptoms and serum apelin level in women with polycystic ovary syndrom syndrome.
Design , Setting and Conduct: 88 samples of obese and overweight women with polycystic ovarian syndrome in the 37-19 year age range will be divided into two groups. The study randomized, double-blind clinical trial will be conducted in two phases.At the first variables measured and after probiotic supplement and placebo will be available to participants. After 12 weeks at the end of intervening variables will be re-evaluated.
Participant (including major eligibility ctriteria): Inclusion criteria;Obese and overweight women (BMI≤25); in the age range 37-19 years, with polycystic ovary syndrome
Non-inclusion criteria; history of systemic and chronic diseases; smoking; The use of some medications, supplements and diets less than two months from the start of the study
Exclusion criteria; pregnancy and infertility complaints during the study
Intervention: The control group will receive placebo and the intervention group will receive probiotic supplement Lactocare (Zist Takhmir company) in the form of capsules containing 500 mg orally, twice daily for 12 weeks.
Main outcome measures( primary and secondary outcome variables): Body mass index, insulin resistance , insulin sensitivity and serum apelin level and secondary level, lipid profiles, sex hormone levels and changes in their symptoms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014110515536N2
Registration date:2015-12-19, 1394/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-19, 1394/09/28
Registrant information
Name
Mohammad Javad Hosseinzadeh
Name of organization / entity
School of Nutritional Sciences and Dietetics, TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 8899 3059
Email address
mhosseinzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-09-25, 1394/07/03
Expected recruitment end date
2016-04-22, 1395/02/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surrvey the effect of Probiotic Supplement on antropometric indexes, hormonal and metabolic parameters, clinical symptoms and serum apelin level in women with polycystic ovary syndrom
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Public title
Surrvey The effect of probiotic supplementation on weight changes, hormonal and metabolic levels in women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women 37-19 years old; Obese and overweight (BMI≤25); Diagnosis of polycystic ovary syndrome (PCOS diagnosis based on the Rotterdam criteria 2003)
Non-inclusion criteria: history of systemic and chronic diseases; smoking; The use of some medications, supplements and diets less than two months from the start of the study
Exclusion criteria: pregnancy; During the study complained of infertility
Age
From 19 years old to 37 years old
Gender
Female
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
How randomized using of closed envelopes method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of Medical Sciences
Street address
Ghods st، keshavarz blv
City
Tehran
Postal code
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IRTUMS.REC.1394.809
Health conditions studied
1
Description of health condition studied
Poly cystic ovary syndrom
ICD-10 code
Endocrine,
ICD-10 code description
E28.2
Primary outcomes
1
Description
Body mass index
Timepoint
Before and 3 month after the intervention
Method of measurement
Calculated by the formula
2
Description
Insulin resistance and insulin sensitivity
Timepoint
Before and 3 month after the intervention
Method of measurement
Calculated by the formula
3
Description
Plasma apelin level
Timepoint
Before and 3 month after the intervention
Method of measurement
Laboratory method
Secondary outcomes
1
Description
lipid profiles level
Timepoint
Before and 3 month after the intervention
Method of measurement
Laboratory method
2
Description
Sex hormones level
Timepoint
Before and 3 month after the intervention
Method of measurement
Laboratory method
3
Description
Changing clinical symptoms
Timepoint
Before and 3 month after the intervention
Method of measurement
Through questionnaires and clinical examination
Intervention groups
1
Description
control group:plasebo,capsule 500mg,2times/day,for12 week