PCOS, is a common disorder that almost 10 percent of women of childbearing age are affected. This syndrome is the most important cause of oligoovulation and unovulation in infertile women and in the general population and is one of the most common endocrine disorders.This syndrome, causes infertility and potentially serious metabolic risks in women. Obesity is an important risk factor in women with polycystic ovary syndrome which causes many symptoms of the syndrome. Studies have shown that weight loss of 5% of initial weight within 6 months in 75% of women have reduced levels of insulin and free testosterone. At least 5%weight loss of initial body weight for achieving clinical and biochemical benefits, including increased rates of pregnancy is required. Green tea is produced with processing the leaves of tea immediately after collection. All polyphenolic components of tea are catechin degradation which produce heat through inhibition of norepinephrine. Another mechanism that may cause catechin can inhibit angiogenesis and production adipose tissue and thereby reduce the weight. Therefore, managing PCOS with emphasize on lifestyle changes and weight loss in obese and overweight women is important. Accordingly, researchers intend to study the effects of green tea on weight loss and hormonal parameters in overweight and obese patients with PCOS do.
In this double-blind (neither the patient nor the person providing medicine to the patient is not aware of the group assignment as drug and placebo. As drug and placebo are named as A and B, and only the researcher is aware of them) randomized (over time, as patients are entered into study, will be assigned one to control group and another one to intervention group) clinical trial groups, 70 women with PCOS and overweight or obesity will be randomly divided into two groups. Our study population are patients with PCOS referred to Alzahra University Hospital in the Isfahan city aged between 20 and 40 years.
The intervention group will receive tea tablets 500 mg (2 times a day for 12 weeks) and the control group placebo. Body mass index, free testosterone and serum insulin concentrations will be measured by Enzyme-Linked Immunosorbent Assay (ELIZA) method. Fasting serum glucose was measured by the enzyme-calorimetric method and insulin resistance index (HOMA-IR) will be measured by the calculation of relevant equation at baseline and after twelve weeks in the two groups.
None of the women in the study, do not take medicine due to infertility or hirsutism. In addition, according to thermogenesis effect of green tea on weight loss, physical activity levels of patients will be determined and considered as a moderating factor.