Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)
NCT04738409 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2023-12-08
Summary
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
- Polycystic Ovary Syndrome
Interventions
- OTHER
-
Lifestyle intervention
The purpose of the research is to evaluate the potential of a multidimensional lifestyle program for PCOS girls. The primary aim is to verify the effectiveness of a 16-week AID intervention vs. HCD (combined with PA\&T), in terms of improvement in androgens level and immune-metabolic risk parameters
- OTHER
-
Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls
The purpose of the intervention is to evaluate the effectiveness of the anti-inflammatory diet (AIDiet) among normal weight (N) and overweight/obese (Ov/Ob) women with PCOS.
Sponsors & Collaborators
-
National Science Centre, Poland
collaborator OTHER_GOV -
Poznan University of Medical Sciences
collaborator OTHER -
Poznan University of Physical Education
lead OTHER
Principal Investigators
-
Małgorzata Mizgier, PhD · Poznan University of Phisical Education, Dietetic Department
-
Justyna Opydo-Szymaczek, PhD · Poznan University of Medical Scienses
-
Grażyna Jarząbek-Bielecka, PhD · Poznan University of Medical Scienses
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Max Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2020-09-01
- Completion
- 2025-12-31
Countries
- Poland
Study Locations
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