NCT04738409

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Poznan University of Physical Education · Academic / Other
• Sex: Female
• Age: 13 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Hyperandrogenism in women is a state of increased androgen production, manifested by irregular menstrual cycles, a more frequent incidence of infertility, metabolic syndrome, oxidative stress, and inflammation, as well as acne and hirsutism. In addition to ovulation disorders and the multifollicular ovaries structure in an ultrasound examination, hyperandrogenism is a typical clinical feature of the Polycystic Ovary Syndrome (PCOS), which is diagnosed in approximately 8.6% of adolescent girls. Excessive body weight makes it difficult to diagnose at an early stage of the disease and intensifies metabolic and hormonal disorders, as well as those related to oxidative stress and inflammation of the body. Some research studies suggest that PCOS may negatively affect oral health of women, increasing the risk of periodontal problems. The main purpose of this research was to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet. The investigators aimed 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). The objective was also to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake, such as carbohydrates and fiber, protein (animal, plant), fats and cholesterol in normal and overweight/obese girls with clinical features of PCOS. Additionally, the investigators would like to evaluate 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

Type	Name	Description
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.

Timeline

• Start date: 2018-04-01
• Primary completion: 2020-09-01
• Completion: 2025-12-31
• First posted: 2021-02-04
• Last updated: 2023-12-08

Locations

2 sites across 1 country: Poland