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Effect of Prebiotic in Clinical and Paraclinical Parameters of Poly Cystic Ovarian Syndrom (PCOS)

Not Applicable
Conditions
clinical parameters.
Polycystic ovarian syndrome
Registration Number
IRCT2016062810324N33
Lead Sponsor
Vice chancellor for research, Tabriz University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
62
Inclusion Criteria

Confirming the diagnosis of PCOS by research collaborator; Age between 18 and 45 years old; Having literacy of reading and writing for completing the questionnaires; BMI between 25 and 40 kg/m2; Not taking of probiotic, prebiotics, vitamins, minerals and omega-3 during the study and three months before the intervention
Exclusion criteria: Having other androgenic disorders such as adrenal hyperplasia or Androgen-secreting tumor according to assessment of research collaborator; Having thyroid diseases according to assessment of research collaborator; Having Cushing's syndrome according to assessment of research collaborator; Using of hormonal contraceptive drugs at present or previous use of hormone therapy; Pregnancy or breast-feeding; Having previous surgery on one or both ovaries; Using of cigarettes and alcohol; Severe physical activity (this is activity that during carrying out it, an individual can’t easily talk due to increased respiratory rate and breathing); Using of Dietary supplements

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Hirsutism Score. Timepoint: Before study, three and six months after starting the intervention. Method of measurement: Ferriman–Gallwey criteria.;Serum Levels of hormonal indices (DHEA-S, free testostrone). Timepoint: Before study and three months after starting the intervention. Method of measurement: Blood tests.
Secondary Outcome Measures
NameTimeMethod
Anthropometric indices (Waist circumference, hip circumference and body mass index). Timepoint: before intervention, three and six months after starting the intervention. Method of measurement: Measuring with centimeter and scale.;Serum levels of FBS, hsCRP and Lipid profile. Timepoint: before intervention and three months after starting the intervention. Method of measurement: Blood tests.;Side events. Timepoint: During the study. Method of measurement: Checklist.
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