Ovarian Hyperandrogenism in Normal and Excessive Body Weight Adolescent Girls and Their Relation to Diet (HAstudy)

NCT04738409 | Unknown

• 1 other identifier: HA000001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The objective was

1. 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. 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. 3.to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake
4. 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Disordered Eating Attitudes

  2018-2022

• Inflammation and Oxidative Stress

  2018-2022

• Nutrition evaluation

  2018-2022

Study Arms (3)

Ov/Ob group

EXPERIMENTAL

PCOS subjects (Overweight/Obesity)

Other: Lifestyle intervention; Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

N group

EXPERIMENTAL

PCOS subjects (Normal weight)

Other: Lifestyle intervention; Other: Effects of AIDiet intervention to improve diet quality, immuno-metabolic health in normal and overweight PCOS girls

H group

NO INTERVENTION

Healthy control subjects

Interventions

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

N group; Ov/Ob group

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.

N group; Ov/Ob group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Poznan University of Physical Education: lead
• National Science Centre, Poland: collaborator
• Poznan University of Medical Sciences: collaborator

Study Sites (2)

Poznan University of Medical Sciences

Poznan, 61-701, Poland

Location

Poznan University of Physical Education

Poznan, 61-871, Poland

Location

Related Publications (4)

• 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.

  PMID: 38347150 DERIVED

• 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.

  PMID: 35010948 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.

  PMID: 34441766 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.

  PMID: 33801995 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 4, 2021
• Study Start: April 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: December 31, 2025
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

PL (2)