Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)
NCT ID: NCT04738409
Last Updated: 2023-12-08
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2018-04-01
2025-12-31
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ov/Ob group
PCOS subjects (Overweight/Obesity)
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
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.
N group
PCOS subjects (Normal weight)
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
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.
H group
Healthy control subjects
No interventions assigned to this group
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* medications of continuous use,
* the use of hormonal therapy or antibiotics in the past three months,
* vitamin or supplements use,
* alcohol consumption
* smoking
13 Years
18 Years
FEMALE
No
Sponsors
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National Science Centre, Poland
OTHER_GOV
Poznan University of Medical Sciences
OTHER
Poznan University of Physical Education
OTHER
Responsible Party
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Małgorzata Mizgier
Assistant Professor
Principal Investigators
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Małgorzata Mizgier, PhD
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Phisical Education, Dietetic Department
Justyna Opydo-Szymaczek, PhD
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Medical Scienses
Grażyna Jarząbek-Bielecka, PhD
Role: PRINCIPAL_INVESTIGATOR
Poznan University of Medical Scienses
Locations
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Poznan University of Medical Sciences
Poznan, , Poland
Poznan University of Physical Education
Poznan, , Poland
Countries
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References
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Mizgier 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.
Mizgier 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.
Mizgier 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.
Mizgier 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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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HA000001
Identifier Type: -
Identifier Source: org_study_id