The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
The study participants are 15 women with PCOS between the ages of 19-40. All participants
must be in good health, non-smokers, and not pregnant or lactating. For three days prior to
both study visits, participants follow a standard 2,000 calorie meal plan of approximately
30% fat, 55% carbohydrate and 15% protein. On the morning of the two study visits,
participants arrive at the General Clinical Research Center at 0700 h. A venicatheter is
inserted into an antecubital vein for collection of blood samples and the catheter is kept
open with saline. A baseline blood sample is taken for measurement of estradiol,
progesterone, glucose, insulin, testosterone, and sex hormone binding globulin (SHBG).
Participants are then served the test meal and asked to consume it within 15 minutes. The
high-fat, low-fiber and low-fat, high-fiber meals are isocaloric and are 62% and 6% fat, 24%
and 81% carbohydrate, and have 1g and 26.8g of fiber, respectively. After each meal, a
blood sample is taken at 30 minutes and every hour for six hours for measurement of
testosterone, SHBG, glucose and insulin. During this time participants remain comfortably
seated or reclined. After the last blood draw, the catheter was removed and participants are
given a complementary meal.
Interventional
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Testosterone
Richard S Legro, M.D.
Principal Investigator
Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine
United States: Federal Government
K24-HD0147-6
NCT00455338
May 2005
November 2006
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