IRCT20190407043193N1已完成2 期
Study of the effect of canola and olive oils consumption on anthropometric, inflammatory, glycemic and hormonal indices, lipid profiles, grade of fatty liver and mood disorder score in patients with polycystic ovary syndrome
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 45 years（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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)
研究者
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