Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00455338
Status:
COMPLETED
Last Update Posted:
2007-04-03
First Post:
2007-04-02
Brief Title:
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 2000 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 268g 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None