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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455338
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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:


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

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00455338     History of Changes
Other Study ID Numbers: K24-HD0147-6
First Submitted: April 2, 2007
First Posted: April 3, 2007
Last Update Posted: April 3, 2007
Last Verified: April 2007

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
meal
composition
postprandial
PCOS
androgen

Additional relevant MeSH terms:
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents