NCT04738409

Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)

Status unknown NA Last updated 8 December 2023

What this trial tests

NA trial testing Lifestyle intervention in Polycystic Ovary Syndrome in 200 participants. Status unknown.

Timeline

1 April 2018

Primary endpoint
1 September 2020

31 December 2025

Quick facts

Lead sponsor	Poznan University of Physical Education
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	200
Start date	1 April 2018
Primary completion	1 September 2020
Estimated completion	31 December 2025
Sites	2 locations across Poland

Drugs / interventions tested

• Lifestyle intervention
• Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

Conditions studied

• Polycystic Ovary Syndrome — all drugs for Polycystic Ovary Syndrome →

Sponsor

Poznan University of Physical Education

Who can join

Adults 13 to 18, female only, with Polycystic Ovary Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Relation between Inflammation, Oxidative Stress, and Macronutrient Intakes in Normal and Excessive Body Weight Adolescent Girls with Clinical Features of Polycystic Ovary Syndrome.
   Mizgier M, Jarząbek-Bielecka G, Wendland N, Jodłowska-Siewert E, et al · · 2021 · cited 35× · PMID 33801995 · DOI 10.3390/nu13030896
2. Dietary and Physical Activity Habits in Adolescent Girls with Polycystic Ovary Syndrome (PCOS)-HAstudy.
   Mizgier M, Jarząbek-Bielecka G, Formanowicz D, Jodłowska-Siewert E, et al · · 2021 · cited 18× · PMID 34441766 · DOI 10.3390/jcm10163469
3. Association of Macronutrients Composition, Physical Activity and Serum Androgen Concentration in Young Women with Polycystic Ovary Syndrome.
   Mizgier M, Watrowski R, Opydo-Szymaczek J, Jodłowska-Siewert E, et al · · 2021 · cited 9× · PMID 35010948 · DOI 10.3390/nu14010073
4. Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls: a pilot study.
   Mizgier M, Więckowska B, Formanowicz D, Lombardi G, et al · · 2024 · cited 7× · PMID 38347150 · DOI 10.1038/s41598-024-54100-1
5. The correlations between serum bone biomarkers and those related to metabolic and hormonal profile, low-grade inflammation and redox balance, in lean and overweight PCOS adolescent girls.
   Mizgier M, Sansoni V, Więckowska B, Jarząbek-Bielecka G, et al · · 2025 · cited 5× · PMID 40704316 · DOI 10.3389/fnut.2025.1477992