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The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

19 Years
40 Years
Not Enrolling
Polycystic Ovary Syndrome

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Trial Information

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.

Inclusion Criteria:

- Chronic oligo/anovulation – intermenstrual periods of ≥ 45 days or ≤ 8 menses per

- 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Richard S Legro, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Federal Government

Study ID:




Start Date:

May 2005

Completion Date:

November 2006

Related Keywords:

  • Polycystic Ovary Syndrome
  • meal
  • composition
  • postprandial
  • PCOS
  • androgen
  • Polycystic Ovary Syndrome