Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

NCT ID: NCT00455338

Last Updated: 2007-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-11-30

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 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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Meal Composition

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Chronic oligo/anovulation - intermenstrual periods of ≥ 45 days or ≤ 8 menses per year.
• Hyperandrogenemia - elevated total testosterone or free androgen index (ratio of testosterone/SHBG x 100). To participate in the study, women must have total testosterone >50 ng/dL or a free androgen index >1.5
• In good general health

Exclusion Criteria

• Currently pregnant or lactating
• Use of confounding medications such as oral contraceptives or other hormonal medication, lipid lowering medications or insulin sensitizing agents such as metformin or the glitazones.
• Tobacco use
• Alcohol consumption of more than two drinks per day
• Unusual meal patterns (including no breakfast, breakfast before 6 am or breakfast after 10am.
• Untreated hyperprolactinaemia (Prolactin >25ng/ml)
• Uncontrolled hypothyroidism
• History of blood clotting disorder
• Diagnosis of anemia at baseline visit
• Presence or history of diabetes mellitus
• Existence of an organic intra cranial lesion such as a pituitary tumor.
• Presence or history of coronary artery disease

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: lead

Principal Investigators

Richard S Legro, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine

Other Identifiers

K24-HD0147-6

Identifier Type: -

Identifier Source: org_study_id