Polycystic Ovary Syndrome (PCOS) Women Clinical Trial
Official title:
Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
The objective of this study is to investigate the effects of two isocaloric maintenance
diets with different meal timing distribution on insulin resistance hyperandrogenism and
cytochrome P450c17 alpha activity in lean PCOS women.
The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist
in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high
calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to
OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.
Hyperinsulinemia plays a central role in the pathogenesis in obese as well as in lean PCOS
women. These women are insulin resistant and have compensatory hyperinsulinemia that
stimulates ovarian cytochrome P450c17 alpha activity that in turn stimulates ovarian
androgen concentrations.
In obese PCOS women, weight loss improves insulin resistance and hyperandrogenism, resulting
in improvement of clinical symptoms.
Since lean PCOS women do not have the option of weight loss, it is important to know if
composition and meal timing distribution may influence glucose metabolism and
hyperandrogenism and cytochrome P450c17 alpha activity. 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
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment