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
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring meal, composition, postprandial, PCOS, androgen
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
Sites / Locations
Outcomes
Primary Outcome Measures
Testosterone
Secondary Outcome Measures
SHBG
Glucose
Insulin
Full Information
NCT ID
NCT00455338
First Posted
April 2, 2007
Last Updated
April 2, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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
We'll reach out to this number within 24 hrs