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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Meal Composition
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring meal, composition, postprandial, PCOS, androgen

Eligibility Criteria

19 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Testosterone

    Secondary Outcome Measures

    SHBG
    Glucose
    Insulin

    Full Information

    First Posted
    April 2, 2007
    Last Updated
    April 2, 2007
    Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00455338
    Brief Title
    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

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    November 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome
    Keywords
    meal, composition, postprandial, PCOS, androgen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    16 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Meal Composition
    Primary Outcome Measure Information:
    Title
    Testosterone
    Secondary Outcome Measure Information:
    Title
    SHBG
    Title
    Glucose
    Title
    Insulin

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard S Legro, M.D.
    Organizational Affiliation
    Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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