- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00455338
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
April 2, 2007 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
16
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Testosterone
|
Secondary Outcome Measures
Outcome Measure |
---|
Insulin
|
Glucose
|
SHBG
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard S Legro, M.D., Department of Obstetrics and Gynecology; Pennsylvania State University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Study Completion (Actual)
November 1, 2006
Study Registration Dates
First Submitted
April 2, 2007
First Submitted That Met QC Criteria
April 2, 2007
First Posted (Estimate)
April 3, 2007
Study Record Updates
Last Update Posted (Estimate)
April 3, 2007
Last Update Submitted That Met QC Criteria
April 2, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- K24-HD0147-6
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Polycystic Ovary Syndrome
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Cairo UniversityCompleted
-
Alexandria UniversityRecruitingPolycystic Ovary Syndrome (PCOS)Egypt
-
Saudi German Hospital - MadinahCompletedPolycystic Ovary Syndrome (PCOS)Saudi Arabia
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University of CopenhagenCompletedPolycystic Ovary Syndrome (PCOS)Denmark
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Odense University HospitalCompleted
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Poznan University of Medical SciencesUniversity of California, DavisUnknownPolycystic Ovary Syndrome (PCOS)Poland
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Assaf-Harofeh Medical CenterUnknownInfertility | Polycystic OvariesIsrael
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Mansoura UniversityNot yet recruitingPCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
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Riphah International UniversityCompleted
-
Dexa Medica GroupCompletedPolycystic Ovary Syndrome (PCOS)Indonesia
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