Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

NCT05768724 | Completed DMC

• 1 other identifier: Gazi University Medicine
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted to evaluate the efficacy of the MEtabolic Syndrome REduction in NAvarra (RESMENA) diet versus a control diet based on American Heart Association (AHA) recommendations for the treatment of PCOS in adolescents with obesity and PCOS. A total of 40 adolescents diagnosed with PCOS between the ages of 13-18 years were randomized to either a Resmena or control diet for 6 months. Dietary status, anthropometry, body composition, biochemical parameters, and reproductive endocrine hormones were compared between the 2 groups before and after the intervention.

Conditions

Polycystic Ovary Syndrome; Obesity; Androgen; Hypersecretion; Diet, Healthy

Outcome Measures

Primary Outcomes (14)

• Luteinizing hormone (LH) (IU/L)

  Participants' serum LH levels was determined.

  change between the first day and the sixth month of the study

• Follicle-stimulating hormone (FSH) (IU/L)

  Participants' serum FSH levels was determined.

  change between the first day and the sixth month of the study

• Total and free (ng/mL)

  Participants' serum FSH levels was determined.

  change between the first day and the sixth month of the study

• Prolactin (ng/mL)

  Participants' serum prolactin levels was determined.

  change between the first day and the sixth month of the study

• Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)

  Participants' serum DHEA-S levels was determined.

  change between the first day and the sixth month of the study

• Androstenedione (ng/mL)

  Participants' serum androstenedione was determined.

  change between the first day and the sixth month of the study

• 17-hydroxyprogesterone (17-OH progesterone) (ng/mL)

  Participants' serum 17-OH progesterone was determined.

  change between the first day and the sixth month of the study

• Sex hormone binding globulin (SHGB) (nmol/L)

  Participants' serum SHGB was determined.

  change between the first day and the sixth month of the study

• Free Androgen Index (FAI)

  Free Androgen Index (FAI) was calculated according to the equation FAI = \[(Total testosterone/ SHBG) × 100\]

  change between the first day and the sixth month of the study

• The Ferriman-Gallwey score (FGS)

  The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.

  change between the first day and the sixth month of the study

• fasting blood glucose (mg/dl)

  Participants' fasting blood gucose was calculated.

  change between the first day and the sixth month of the study

• fasting insulin (IU/ml)

  Participants' fasting insulin was calculated.

  change between the first day and the sixth month of the study

• HOMA-IR index

  Participants' HOMA-IR index value was calculated using the "fasting blood glucose (mmol/L) x fasting insulin (μU/mL)/22.5" formula

  change between the first day and the sixth month of the study

• QUICKI index

  Participants' QUICKI index was calculated using the 1/\[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)\].

  change between the first day and the sixth month of the study

Secondary Outcomes (13)

• Total cholesterol (mg/dl) composition

  change between the first day and the sixth month of the study

• high-density lipoprotein (HDL-C) (mg/dl)

  change between the first day and the sixth month of the study

• low-density lipoprotein (LDL) (mg/dl)

  change between the first day and the sixth month of the study

• triglyceride (mg/dl)

  change between the first day and the sixth month of the study

• high-sensitivity CRP (HsCRP)(mg/l)

  change between the first day and the sixth month of the study

Study Arms (2)

İntervention group

EXPERIMENTAL

METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS

Behavioral: intervention diet

conrol group

EXPERIMENTAL

American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS

Behavioral: control diet

Interventions

intervention diet BEHAVIORAL

The Resmena diet: It was characterized by a higher meal frequency, consisting of seven meals/d (including breakfast, lunch, dinner, and two snacks in the morning and two snacks in the afternoon), and by a different macronutrient distribution; 40% total energy value from CHO, 30% from proteins and 30% from lipids. This pattern tried to reinforce high n-3 polyunsaturated FA (n-3 PUFA) and high natural antioxidant food consumption and promoted low GL CHO intake as well as a high adherence to the Mediterranean diet. It also maintained a healthy FA profile and a cholesterol content of less than 300 mg/day. * Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked.

İntervention group

control diet BEHAVIORAL

Control diet: It was based on the American Heart Association (AHA) guidelines, including 3-5 meals per day, a macronutrient distribution of 55% total energy value from carbohydrates, 15% proteins, and 30% lipids, a healthy fatty acids (FA) profile and a cholesterol consumption lower than 300 mg/day. \- Daily meal plans were created according to the energy intake of the participants and sent to the participants via social media every week. Participants were asked to keep 3-day diet records to evaluate their compliance with the diet and were invited to the research center once a month to be checked

conrol group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Gender Eligibility Details: adolescent girls with obesity and PCOS
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria
• Age 13-18 years,
• Body mass index (BMI) ≥ 95th percentile

You may not qualify if:

• Other endocrine etiological disorders (Cushing's syndrome, congenital adrenal hyperplasia, McCune Albright syndrome, mutations in the glucocorticoid receptor gene, ovarian and adrenal androgen-secreting tumors, hyperprolactinemia, diabetes mellitus, thyroid dysfunction, adrenal, and other endocrine disorders),
• Cardiovascular and cerebrovascular diseases,
• Hematologic disorders
• Liver and kidney failure
• Mental disorders
• Eating disorders
• Contraceptive use in the last 3 months
• Use of insulin-sensitizing agents
• Use of drugs affecting lipid metabolism (such as fish oil)
• Smoking.

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Esra Döğer

Ankara, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

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; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rukiye BOZBULUT, Dr

  Gazi Univeristy

  STUDY CHAIR

• Mahmut Orhun Çamurdan, prof

  Gazi University

  STUDY CHAIR

• Aysun Bideci, prof

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All cases were assigned codes. The codes were sealed in opaque envelops and kept in statistician ofce until the last patient completed the study.Study personnel involved in the analysis of the results (endocrinologist, radiologist, nurse, and laboratory technicians) were blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-blind, randomized, two-arm, parallel six-month dietary intervention.

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 14, 2023
• Study Start: January 1, 2021
• Primary Completion: December 5, 2021
• Study Completion: February 1, 2022
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)