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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Lifestyle intervention; Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznan, Poland, 61-701
    • Poznan University of Medical Sciences
  • Poznan, Poland, 61-871
    • Poznan University of Physical Education

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Study Population

Caucasian adolescents girls, aged 13-18 years

Description

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:

• 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:

• any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors
• medications of continuous use,
• the use of hormonal therapy or antibiotics in the past three months,
• vitamin or supplements use,
• alcohol consumption
• smoking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ov/Ob group; PCOS subjects (Overweight/Obesity)	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.
Experimental: N group; PCOS subjects (Normal weight)	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.
No Intervention: H group; Healthy control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	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	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	Severity of gingivitis expressed as a Gingival Index (GI); Presence of gingivitis assessed based on the percentage of sites bleeding upon probing BOP%.; The subgingival microflora assessed on the basis of the number of specific bacteria isolated from gingival sulci of every individual and the percentage of patients affected by specific periodontal pathogens.; Salivary levels of TNF-alfa, IL-6, IL-1B, uric acid used to assess and compare the inflammation in oral environment.; Testosteron in saliva used to compare androgenic status of patients with PCOS and healthy controls.	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

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education
• Collaborators: Poznan University of Medical Sciences; National Science Centre, Poland
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Congenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Hyperandrogenism
• Other Study ID Numbers: HA000001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No