Clinical trial NCT00455338: Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Official title: The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: meal
composition
postprandial
PCOS
androgen
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
First posted: 2007-04-03
Enrollment: 16
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Testosterone
Secondary outcomes:
measure: SHBG
measure: Glucose
measure: Insulin
Other outcomes:
Locations:
Study officials:
affiliation: Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine
name: Richard S Legro, M.D.
role: PRINCIPAL_INVESTIGATOR
References: