IRCT20140907019082N9CompletedPhase 3
The effects of oral thylakoid intake on the metabolic, hormonal and inflammatory parameters in obese women with polycystic ovary syndrome under hypocaloric diet: A randomized double-blinded placebo controlled trial
Vice chancellor for research , Tabriz University of Medical Sciences,0 sites48 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 48
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20 years to 45 years (—)
- Sex
- Female
Inclusion Criteria
- •All patients in our selected population were diagnosed with polycystic ovary syndrome according to Rotterdam diagnostic criteria with the diagnosis of the gynecologist.Having at least two of the three following symptoms:1-Abnormal menstrual cycles (oligomenorrhea, amenorrhea)2- Polycystic ovary in ultrasound3- Clinical signs of hyperandrogenism (Acne- Hirsutism) or biochemical symptoms of hyperandrogenism.
- •Women aged 20-40 years
- •Body Mass Index (BMI) range: 30-40 Kg/m2
- •Moderate activity level
- •Only OCP consumer (estrogen and progesterone combination pills). All participants will only receive OCP.
- •Willingness to participate in the study
Exclusion Criteria
- •Pregnancy(tendency to become pregnant) or lactation
- •Having any illness that affecting the studied variables (such as liver disease, thyroid disease, cardiovascular disease, renal disease, gastrointestinal disease , Cushing's syndrome,adrenal hyperplasia, androgen-secreting tumors , hyperprolactinemia).
- •Insulin infusion and intakes of blood pressure regulating drugs, statins and or drugs that affect insulin resistance (such as metformin), thiazolidinedione, anti androgens.
- •Using of any vitamin and mineral supplements and or antioxidants or being under certain diets at least two months before the study.
- •Any changes in the therapeutic protocol during the study
Investigators
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