Clinical trial · Interventional
Effect of Meal Composition on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
The Effect of Meals of Varying Fat and Fiber Content on Postprandial Testosterone Concentration in Women With Polycystic Ovary Syndrome
NCT00455338CI-TRIAL-00000657completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Meal Composition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Testosterone
Secondary outcomes (3)
- measure
- SHBG
- measure
- Glucose
- measure
- Insulin
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.