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| Name | Class |
|---|---|
| National Science Centre, Poland | OTHER_GOV |
| Poznan University of Medical Sciences | OTHER |
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The objective was
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ov/Ob group | Experimental | PCOS subjects (Overweight/Obesity) |
|
| N group | Experimental | PCOS subjects (Normal weight) |
|
| H group | No Intervention | Healthy control subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blood parameters | Hormonal and biochemical parameters, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, androstenedione, estradiol, dehydroepiandrosterone (DHEA-S), Sex Hormone Binding Globulin (SHBG), fasting glucose and fasting insulin, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), 17 OH-Progesterone, Prolactin, Cortisol, Thyroid-stimulating hormone (TSH), will be measured in the morning after overnight fasting. | 2018-2022 |
| Anthropometric Assessment | Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height². Weight will be measured to the nearest 0.1 kg using digital medical scales. Height will be measured with a stadiometer attached to the scales. Waist circumference (WC) will be measured to the nearest 0.1 mm using anthropometric tape between the lower border of rib margin and the upper border of iliac crest (WC-mid). | 2018-2022 |
| Body Composition | Body composition will be assessed with a body composition analyzer (BIA method). The measurements of fat mass (FM) will be expressed as a percentage (%) and kilograms (kg). | 2018-2022 |
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| Measure | Description | Time Frame |
|---|---|---|
| Disordered Eating Attitudes | Eating behavior will be assessed with a standard Eating Attitudes Test-26 (EAT-26), a self-administrated questionnaire. | 2018-2022 |
| Inflammation and Oxidative Stress | Serum concentrations of the inflammation markers: Interleukin 1 (IL-1), Interleukin 6 (IL-1), Tumor Necrosis Factor (TNF-α), C-reactive protein (CRP) and the markers of oxidation: malondialdehyde, total antioxidant capacity will be measured with a commercial ELISA assay kits |
Inclusion Criteria:
The criteria for the patient's inclusion were based on the 2003 Rotterdam criteria, with the presence of at least two of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Małgorzata Mizgier, PhD | Poznan University of Phisical Education, Dietetic Department | Principal Investigator |
| Justyna Opydo-Szymaczek, PhD | Poznan University of Medical Scienses | Principal Investigator |
| Grażyna Jarząbek-Bielecka, PhD | Poznan University of Medical Scienses | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poznan University of Medical Sciences | Poznan | 61-701 | Poland | |||
| Poznan University of Physical Education |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38347150 | Derived | 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. | |
| 35010948 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2021 | Jan 29, 2021 |
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| Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls | Other | 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. |
|
| 2018-2022 |
| Nutrition evaluation | Nutrition evaluation will be conducted by continuous recording of all consumed foodstuffs, dishes and beverages, specifying home measures and weight (3-day food record method and food frequency method FFQ). Data will be analysed using The Aliant computer program (Cambridge Diagnostics). | 2018-2022 |
| Oral Health Assessment |
| 2018-2022 |
| Evaluation of physical activity | International Physical Activity Questionnaire will be applied, including records of the type and specific character of the training and activity, its duration, intensity and frequency. | 2018-2022 |
| The Data From The Child's Health Book | Collected from the child's health book regarding newborn body weight and term of delivery. The incidence of macrosomia (body weight over 4000 g) or low birth weight, LBW (body weight less than 2500 g) was assessed on the basis of the newborn's body weight. The full term of delivery (term births) will be assessed for deliveries that occur between 38-42 weeks of pregnancy, while preterm births will be defined as those deliveries between 23 weeks and 37 weeks | 2018-2022 |
| Poznan |
| 61-871 |
| Poland |
| 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. |
| 34441766 | Derived | 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. |
| 33801995 | Derived | 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. |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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