Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
The primary objective is to determine if meals of different fat and fiber content affect postprandial plasma testosterone concentration in women with polycystic ovary syndrome. Our hypothesis is that a high-fiber meal will have a greater reduction in testosterone composition compared with a high-fat meal.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome|
|Study Start Date:||May 2005|
|Study Completion Date:||November 2006|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455338
|Principal Investigator:||Richard S Legro, M.D.||Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine|