An interventional study of Dietary intervention in Hyperandrogenism and Insulin Resistance, sponsored by Tel Aviv University. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2015-04-08.
Sponsored by Tel Aviv University · Not applicable, Interventional, and Supportive care
In obese women with polycystic ovary syndrome (PCOS), weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Weight loss is not required in lean PCOS patients; nevertheless, the influence of meal timing and composition on glucose metabolism and hyperandrogenism may have clinical value. In this study the investigators investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS patients.
Insulin resistance and hyperinsulinemia plays a pivotal role in the pathogenesis of polycystic ovary syndrome (PCOS). Hyperinsulinemia stimulates ovarian cytochrome P450c17 alpha activity, in obese and nonobese women with PCOS, thereby increasing serum levels of 17-alpha-hydroxyprogesterone, androgens concentrations, decreasing SHBG and promoting the clinical features of hyperandrogenism.
In women with PCOS, weight loss improves insulin resistance and hyperandrogenism, resulting in improvement of clinical symptoms. Since lean women with PCOS do not have the option of weight loss, it is important to know weather diet composition and meal timing distribution may influence glucose metabolism and hyperandrogenism.
We hypothesized that a timing pattern of increased nutrient intake of protein and carbohydrates in the morning, with decreased caloric intake at night would improve insulin sensitivity and hyperandrogenism in lean women with PCOS.
Objective:The objective of this study is to investigate the effects of two isocaloric diets with different meal timing distribution on insulin resistance and hyperandrogenism in lean PCOS women.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Tel Aviv University is the lead sponsor of 100 studies on the registry; 26 are open to participants now.
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Exclusion Criteria:
Jet lag during the 2 week period immediately prior to study onset
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Lifestyle counseling, with high calorie breakfast
Other: Dietary intervention
Diet with high calorie dinner
Other: Dietary intervention
High Calorie breakfast and high calorie dinner
hyperandrogenism
Androgens will be evaluate at baseline and after one of two isocaloric diet that differe in meal timing distribution
Time frame: 90 days
glucose metabolism
Glucose metabolism will be evaluated at baseline and after one of two isocaloric diets that differ in meal timing distribution
Time frame: 90 days
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Tel Aviv University