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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04738409 on ClinicalTrials.gov