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Polycystic Ovary SyndromeNCT00455338

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

A study testing Meal Composition in people with Polycystic Ovary Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Meal Composition
How many people
16 participants
Where
No sites listed yet
Study dates
May 2005to Nov 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

About this study

Official title: 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.

Read the 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.

Being tested
Meal Composition
Keywords
meal, composition, postprandial, PCOS, androgen
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Meal CompositionBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Testosterone

Secondary outcomes (3)

  1. SHBG

  2. Glucose

  3. Insulin

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2007 (estimated)
  2. Study startMay 2005
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00455338
Sponsor's protocol ID
K24-HD0147-6
Status last verified
Apr 2007
First submitted
2 Apr 2007
Last updated
3 Apr 2007
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Meal Composition in people with Polycystic Ovary Syndrome, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Testosterone. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455338.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2007.

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