Clinical trial · Interventional
Meal Timing on Glucose and Hyperandrogenism in PCOS Women
Influence of Meal Timing on Glucose Metabolism and Hyperandrogenism in Lean Women With Polycystic Ovary Syndrome
- 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 objective of this study is to investigate the effects of two isocaloric maintenance diets with different meal timing distribution on insulin resistance hyperandrogenism and cytochrome P450c17 alpha activity in lean PCOS women. The investigators hypothesis is that in lean PCOS women a Breakfast Diet (BD) which consist in high calorie breakfast and reduced dinner, vs Dinner Diet (DD) which consist in high calorie dinner with reduced breakfast; the BD will improve glucose and insulin response to OGTT and would decrease the hyperandrogenism and cytochrome P450c17 alpha activity.
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 (PCOS) Women | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Comparator: Lifestyle counseling ARM 1 | Other | — | UNRESOLVED |
| Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2 | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lifestyle counseling ARM 1
- description
- Arm 1 Breakfast Diet The arm 1 will be assigned to eat High calorie breakfast (800kcal) and reduced dinner (200 kcal) During 90 days from baseline to the end of the trial (day 90)
- interventionNames
- Other: Active Comparator: Lifestyle counseling ARM 1
- type
- PLACEBO_COMPARATOR
- label
- Lifestyle counseling ARM 2
- description
- Lean PCOS women in the Arm 2 will be assigned to do a dinner diet from day 0 to day 90 of the trial
- interventionNames
- Behavioral: Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2
Primary outcomes (1)
- measure
- Changes in Androgens and 17 alpha hydroxyprogesterone serum levels
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: lean women with Polycystic Ovary BMI below 25 kg/m2 Testosterone above 1.0 ng/ml 17 Oh progesterone below 200 ng/ml US of Polycystic Ovaries Exclusion Criteria: Obesity BMI above 25 kg/m2 Diabetes Mellitus Other endocrine disease like hypothyroidism, late onset adrenal hyperplasia Pregnancy Contraceptive or other hormonal treatment
References
Publications (0)
Data not yet available