Adolescent Polycystic Ovary Syndrome on a Low-carbohydrate Diet (PCOS)

Effect of a Low-carbohydrate Diet on Outcomes According to Phenotype in Juvenile Polycystic Ovary Syndrome

The aim of the study was to investigate the changes in the clinical and biochemical parameters of adolescents on a low-carbohydrate diet in relation to their PCOS phenotype in the 3rd trimester.

Study Overview

• Status: Completed
• Conditions: Polycystic Ovary Syndrome; Diet Habit; Adolescent Behavior
• Intervention / Treatment: Dietary supplement: Low carbonhydrate diet

Detailed Description

Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries, and metabolic abnormalities. In addition, some clinical and laboratory phenotypic features have been defined that were not previously included in the PCOS definition criteria, but which complement the clinical picture and influence the severity and morbidity of the clinical picture. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM.For adult patients, internationally recognized diagnostic criteria have been developed based on combinations of otherwise unexplained hyperandrogenism, anovulation and polycystic ovary and are covered by the Rotterdam Consensus Criteria. However, in the adolescent age group, the frequency of anovulatory cycles and associated menstrual irregularities, the frequent symptoms of hyperandrogenism and acne vulgaris in the developmental phase, the problems with testosterone measurement and the prevalence of polycystic ovarian morphology in normal adolescents complicate the diagnosis.

PCOS is a serious clinical and psychological problem for adolescent girls. Key interventions include lifestyle modification, including diet, physical activity and weight loss. These measures have been shown to alter the course of the disease in overweight and obese girls. In particular, it is known that high glycemic index carbohydrate intake and glycemic load lead to a rapid rise in blood glucose levels and increased insulin production.

It is therefore thought that reducing the amount of insulin could have a more positive effect on PCOS than the usual carbohydrates. A low-carbohydrate diet is an effective, weight-independent approach in the treatment of metabolic disorders in PCOS patients. With this in mind, this study aimed to evaluate the clinical and biochemical outcomes at month 3 after application of the low-carbohydrate diet in adolescents according to their PCOS phenotype.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06000
    • Etlik Zübeyde Hanım

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted based on the 2018 ESHRE/ASRM guideline:

1. Oligo and/or anovulation*

2. Clinical and/or biochemical hyperandrogenism *Oligo and/or anovulation are defined as follows:

   • It is considered normal in the first year after menarche as part of the pubertal transition
   • Between 1-3 years after menarche: < 21 or > 45 days
   • 3 years after menarche - perimenopause: < 21 or > 35 days or < 8 cycles per year
   • 1 year after menarche: >90 days for each menstrual cycle
   • Absence of menstruation at the age of 15 years or 3 years after menarche.

Identification of phenotype groups:

PHENOTYPE A: HA+ OD + PCOM PHENOTYPE B: HA+OD PHENOTYPE C: HA+PCOM PHENOTYPE D: OD+PCOM.

Description

Inclusion Criteria:

• at least 1 year has passed since menarche
• under 24 years old
• patients who have not received an oral contraceptive method and have given verbal and written informed consent will be included.

Exclusion Criteria:

• over 24 years old
• hyperprolactinemia, Cushing's syndrome, congenital adrenal hyperplasia, thyroid diseases
• neuromuscular, liver, pancreatic or gastrointestinal diseases
• hormonal medication such as antiandrogens, antidiabetics, glucocorticoids, insulin sensitizers or lipid regulators

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phenotype A; PHENOTYPE A: Hyperandrogenism + Ovulatory Dysfunction + PCOM	Dietary supplement: Low carbonhydrate diet; Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.; Other Names: 0.; 3.month
Phenotype B; PHENOTYPE B: HA+OD	Dietary supplement: Low carbonhydrate diet; Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.; Other Names: 0.; 3.month
Phenotype C; PHENOTYPE C: HA+PCOM	Dietary supplement: Low carbonhydrate diet; Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.; Other Names: 0.; 3.month
Phenotype D; PHENOTYPE D: OD+PCOM	Dietary supplement: Low carbonhydrate diet; Each patient will receive a 3-month low-carbohydrate (40% CHO) diet from the same dietitian. Whether the patients adhere to the diet and which components the prescribed diet consists of is recorded in detail. After 3 months of standard application, the patient is examined again by the gynecologist and obstetrician at the PCOS clinic.; Other Names: 0.; 3.month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of insulin resistance at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	Calculation of insulin resistance: A fasting blood glucose level between 100-125 mg/dl was considered as 'impaired fasting glucose'. A Homeostatic Model Assessment Insulin Resistance (HOMA-IR) value of ≥2.5 was defined as insulin resistance. Insulin resistance was calculated using the formula of the homeostatic model. [HOMA-IR= fasting glucose (mg/dl)xfasting insulin (mIU/mL)/405].	3 months
demographic datas on the study	Age	3 months
Evaluation of demographic data	Smoking	3 months
Demographic data at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	Body mass index Calculation of BMI: Height and body weight of the patients were measured using professionally calibrated devices. BMI was calculated using the formula BMI = weight (kg)/height (m)2.	3 months
Evaluation of clinical results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	waist circumference(centimeters)	3 months
Evaluation of degree of hirsutism at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	degree of hirsutism (Ferriman-Gallwey Hirsutism Scoring Scale; lowest 8 highest: 24)	3 months
Hormone results at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	prolactin (ng/mL)	3 months
androstenedione at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	androstenedione (mosm/kg)	3 months
dehydroepiandrosterone sulfate at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	dehydroepiandrosterone sulfate (DHEA-S) (μg/dL)	3 months
TSH at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	thyroid stimulating hormone (TSH) (mIU/mL)	3 months
SHBG at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	Hormone test results : sex hormone-binding globulin (SHBG)	3 months
17-OH progesterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	17-OH progesterone (mIU/mL)	3 months
Testosterone at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	free and total testosterone (ng/mL)	3 months
Lipid profile at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	Lipid profile: Total cholesterol (mg/dL), high-density lipoprotein (HDL) cholesterol (mg/dL), low-density lipoprotein (LDL) cholesterol (mg/dL), triglycerides (mg/dL).	3 months
Glucose at month 3 after application of a low-carbohydrate diet according to PCOS phenotypes in adolescents.	fasting blood glucose	3 months

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Investigators: Principal Investigator: Mujde Can Ibanoglu, Ankara Etlik Zubeyde Hanım Women's Health Training and Research Hospital, Ankara, Turkey.

Publications and helpful links

General Publications

• Joham AE, Pena AS. Polycystic Ovary Syndrome in Adolescence. Semin Reprod Med. 2022 Mar;40(1-02):e1-e8. doi: 10.1055/s-0042-1757138. Epub 2022 Sep 12.
• Bozdag G, Mumusoglu S, Zengin D, Karabulut E, Yildiz BO. The prevalence and phenotypic features of polycystic ovary syndrome: a systematic review and meta-analysis. Hum Reprod. 2016 Dec;31(12):2841-2855. doi: 10.1093/humrep/dew218. Epub 2016 Sep 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Actual): October 7, 2024
• Study Completion (Actual): February 25, 2025

Study Registration Dates

• First Submitted: May 18, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: polycystic ovary syndrome; adolescents; phenotype; low carbonhydrate diet
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Pathologic Processes; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease; Genital Diseases, Female; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Syndrome; Polycystic Ovary Syndrome
• Other Study ID Numbers: 01/07 22.01.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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