Clinical trial · Interventional
Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)
Ovarian Hyperandrogenism in Adolescent Girls and Concomitant Metabolic Changes, Oxidative Stress, Inflammation, Oral Health and Their Relation to Diet
- 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 was 1. to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet. 2. to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA (Disordered Eating Attitudes) 3. to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake 4. to assess the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls | Other | — | UNRESOLVED |
| Lifestyle intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Ov/Ob group
- description
- PCOS subjects (Overweight/Obesity)
- interventionNames
- Other: Lifestyle intervention
- Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls
- type
- EXPERIMENTAL
- label
- N group
- description
- PCOS subjects (Normal weight)
- interventionNames
- Other: Lifestyle intervention
- Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls
- type
- NO_INTERVENTION
- label
- H group
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: The criteria for the patient's inclusion were based on the 2003 Rotterdam criteria, with the presence of at least two of the following: * written consent for inclusion (girls and their parents) * clinical and/or biochemical hyperandrogenism (hirsutism with moderate to severe acne, and/or elevation of serum total testosterone or free testosterone, * oligoovulation (based on oligomenorrhea defined as bleeding episodes occurring less than 8 times per year or secondary amenorrhea), * polycystic ovarian picture in an ultrasound examination (at least 12 follicles in each ovary each measuring 2-9 mm in diameter and/or ovarian volume \>10 mL). Exclusion Criteria: * any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors * medications of continuous use, * the use of hormonal therapy or antibiotics in the past three months, * vitamin or supplements use, * alcohol consumption * smoking
References
Publications (4)
- DERIVEDMizgier M, Wieckowska B, Formanowicz D, Lombardi G, Brozek A, Nowicki M, Durkalec-Michalski K, Kedzia W, Jarzabek-Bielecka G. Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls: a pilot study. Sci Rep. 2024 Feb 12;14(1):3525. doi: 10.1038/s41598-024-54100-1. PMID 38347150
- DERIVEDMizgier M, Watrowski R, Opydo-Szymaczek J, Jodlowska-Siewert E, Lombardi G, Kedzia W, Jarzabek-Bielecka G. Association of Macronutrients Composition, Physical Activity and Serum Androgen Concentration in Young Women with Polycystic Ovary Syndrome. Nutrients. 2021 Dec 24;14(1):73. doi: 10.3390/nu14010073. PMID 35010948
- DERIVEDMizgier M, Jarzabek-Bielecka G, Formanowicz D, Jodlowska-Siewert E, Mruczyk K, Cisek-Wozniak A, Kedzia W, Opydo-Szymaczek J. Dietary and Physical Activity Habits in Adolescent Girls with Polycystic Ovary Syndrome (PCOS)-HAstudy. J Clin Med. 2021 Aug 5;10(16):3469. doi: 10.3390/jcm10163469. PMID 34441766
- DERIVEDMizgier M, Jarzabek-Bielecka G, Wendland N, Jodlowska-Siewert E, Nowicki M, Brozek A, Kedzia W, Formanowicz D, Opydo-Szymaczek J. Relation between Inflammation, Oxidative Stress, and Macronutrient Intakes in Normal and Excessive Body Weight Adolescent Girls with Clinical Features of Polycystic Ovary Syndrome. Nutrients. 2021 Mar 10;13(3):896. doi: 10.3390/nu13030896. PMID 33801995