Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome - Full Text View

Sponsored by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00455338

Purpose

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.

Condition	Intervention
Polycystic Ovary Syndrome	Behavioral: Meal Composition

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
Official Title:	The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome

Resource links provided by NLM:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Testosterone

Secondary Outcome Measures:

SHBG
Glucose
Insulin

Estimated Enrollment:	16
Study Start Date:	May 2005
Study Completion Date:	November 2006

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

Ages Eligible for Study:	19 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455338

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Richard S Legro, M.D.

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

More Information

No publications provided

Study ID Numbers:	K24-HD0147-6
Study First Received:	April 2, 2007
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00455338 History of Changes
Health Authority:	United States: Federal Government; United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

meal
composition
postprandial
PCOS
androgen

Study placed in the following topic categories:

Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Ovarian Diseases
Methyltestosterone
Cysts
Hormones

Polycystic Ovarian Syndrome
Testosterone 17 beta-cypionate
Genital Diseases, Female
Testosterone
Polycystic Ovary Syndrome
Endocrinopathy
Ovarian Cysts
Androgens

Additional relevant MeSH terms:

Disease
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Ovarian Diseases
Cysts
Hormones
Pharmacologic Actions

Adnexal Diseases
Genital Diseases, Female
Neoplasms
Testosterone
Pathologic Processes
Syndrome
Polycystic Ovary Syndrome
Ovarian Cysts
Androgens

ClinicalTrials.gov processed this record on September 10, 2009