MedPath

effect of canola and olive oils consumption in polycystic ovary syndrome

Phase 2
Conditions
Polycystic ovary syndrome.
Polycystic ovarian syndrome
E28.2
Registration Number
IRCT20190407043193N1
Lead Sponsor
Esfahan University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
90
Inclusion Criteria

The definitive diagnosis of PCOS based on diagnostic criteria (Rotterdam3) by the physician
The absence of other endocrine disorders or the conditions that lead to some or most of the clinical manifestations and disorders associated with PCOS (such as congenital or non-classic adrenal hyperplasia, Cushing's syndrome, androgens secreting tumors, drugs induced hyperandrogenism, idiopathic hyperandrogenism, hirsutism Idiopathic, thyroid dysfunction, hyperprolactinemia, pregnancy, lactation and menopause)
Non-use of any drug and / or surgical treatment for the clinical symptoms and disorders associated with PCOS other than OCP (such as spironolactone, finasteride, isotretinoin, letrozole, clomiphene, gonadotropins, metformin, cyproterone, rosiglitazone, pioglitazone, ovarian laparoscopic surgery, and Auxiliary reproductive technology)
Absence of any severe or significant systemic disease requiring treatment such as any cancer; digestive, liver or endocrine disorders (such as celiac disease, Crohn's disease, ulcerative colitis), diabetes mellitus, hyperparathyroidism, hypercalcemia, or hyperphosphatemia); cardiovascular disorders (e.g. Uncontrolled hypertension or history of myocardial infarction); kidney disorders (such as renal failure, nephrotic syndrome); blood coagulation disorders (eg thalassemia, hemophilia); neurological disorders (such as epilepsy) or reproductive disorders associated with PCOS Ask a doctor or a patient
Not taking any of these items: tobacco; alcohol; anti-estrogens (such as tamoxifen and raloxifene); oral or injectable corticosteroids (such as prednisone, prednisolone, dexamethasone, triamcinolone, hydrocortisone or betamethasone); lack of omega-3 supplementation Chains and long chains); effective drugs for insulin resistance such as metformin and sitagliptin
Non-consumption of any canola and olive oil in the last 6 months as the main consumer oil
Lack of any allergy, intolerance or harmful drug reaction to the supplementation of the studied oils
Being in the age range of 18-45 years (people are not better off at the age of growth and menopause)
Being in the BMI range above 25 and less than 40
Ability to understand the goals of the study and provide informed written consent
The desire to participate in the study
Weight constant over the past 6 months (self report)
Lack of Pregnancy and Breastfeeding

Exclusion Criteria

The onset of a dose or any change in dosage in the above drugs or the change in the type or dose of OCP consumed during the study period
Getting pregnant during the study period
Incidence of severe side effects or signs of poisoning with supplements used during the study period
Failure to adhere to the study protocol
The acceptance of less than 80% of the intervention (consumption of less than 80% of the total intervention oil that should be consumed during the 10-week intervention period will be considered as a low admission)

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
ipid profile. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Spectrophotometric method.;Anthropometric Indicators. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Measurements with biometric impedance analysis (BIA) and meters.;Fatty liver grade. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: sonography.;Mood disorder score. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: DASS-21 questionnaire.;Inflammatory Indicators. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: ELISA.
Secondary Outcome Measures
NameTimeMethod
Clinical signs including hirsutism and the interval between menstruation. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: MFGS questionnaire And the question of the patient.;Blood pressure. Timepoint: At the beginning of the study, 5 weeks after the intervention and the end of the study. Method of measurement: Mercury barometric.
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