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Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome, Obesity, Androgen; Hypersecretion

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
intervention diet
control diet
Sponsored by
Gazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

13 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Esra Döğer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

İntervention group

conrol group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Luteinizing hormone (LH) (IU/L)
Participants' serum LH levels was determined.
Follicle-stimulating hormone (FSH) (IU/L)
Participants' serum FSH levels was determined.
Total and free (ng/mL)
Participants' serum FSH levels was determined.
Prolactin (ng/mL)
Participants' serum prolactin levels was determined.
Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)
Participants' serum DHEA-S levels was determined.
Androstenedione (ng/mL)
Participants' serum androstenedione was determined.
17-hydroxyprogesterone (17-OH progesterone) (ng/mL)
Participants' serum 17-OH progesterone was determined.
Sex hormone binding globulin (SHGB) (nmol/L)
Participants' serum SHGB was determined.
Free Androgen Index (FAI)
Free Androgen Index (FAI) was calculated according to the equation FAI = [(Total testosterone/ SHBG) × 100]
The Ferriman-Gallwey score (FGS)
The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.
fasting blood glucose (mg/dl)
Participants' fasting blood gucose was calculated.
fasting insulin (IU/ml)
Participants' fasting insulin was calculated.
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
QUICKI index
Participants' QUICKI index was calculated using the 1/[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)].

Secondary Outcome Measures

Total cholesterol (mg/dl) composition
Participants' serum total cholesterol was determined.
high-density lipoprotein (HDL-C) (mg/dl)
Participants' serum HDL-C was determined.
low-density lipoprotein (LDL) (mg/dl)
Participants' serum LDL-C was determined.
triglyceride (mg/dl)
Participants' serum triglyceride was determined.
high-sensitivity CRP (HsCRP)(mg/l)
Participants' serum HsCRP was determined.
tumor necrosis factor-alpha (TNF-α) (pg/ml)
Participants' serum TNF-α determined.
interleukin-6 (IL-6) (pg/ml)
Participants' serum IL-6 determined.
Weight in kilograms
Body weight measurement was made.
Height in meters
Height was measured
BMI = body mass index (kg/m2)
BMI = [body weight (kg)/(height [m])2]' was calculated
Neck circumference in cm
Neck circumference was measured
. Waist circumference in cm
waist circumference was measured
body composition analysis
body composition analysis (fat mass /kg), fat percentage (%), fat-free mass (kg)) were made by using the InBody 720 (1-1000 kHz; InBody Co., Ltd. Korea)

Full Information

First Posted
February 22, 2023
Last Updated
March 3, 2023
Sponsor
Gazi University
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1. Study Identification

Unique Protocol Identification Number
NCT05768724
Brief Title
Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
Official Title
Beneficial Effects of Resemena Diet on Anthropometric, Metabolic and Reproductive Profile in Adolescents With Obesity and Polycystic Ovary Syndrome: a Randomized Controlled Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 5, 2021 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The purpose of this study was to investigate the effect of a high meal frequency, low carbohydrate, high protein, high n-3 PUFA, healthy fatty acid and antioxidant content, low glycemic load Resmena diet or a control diet based on AHA recommendations on anthropometric measurements, body composition, insulin resistance, lipid metabolism levels, inflammatory markers and reproductive endocrine levels in adolescents with obesity and PCOS..Randomized controlled study design was used in the study. Patients in the study were allocated to the control and study intervention groups. Participants were invited to face-to-face interviews at the beginning of the study and monthly for 6 months. Anthropometric measurements, body composition analysis, and a physical activity questionnaire were performed at the beginning and end of the study, and three-day food consumption records and blood samples for the measurement of biochemical parameters were collected. In addition, the physical activity and food consumption records of the participants were repeated in monthly controls and their anthropometric measurements and body composition were analyzed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Obesity, Androgen; Hypersecretion, Diet, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blind, randomized, two-arm, parallel six-month dietary intervention.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention group
Arm Type
Experimental
Arm Description
METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS
Arm Title
conrol group
Arm Type
Experimental
Arm Description
American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS
Intervention Type
Behavioral
Intervention Name(s)
intervention diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
control diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Luteinizing hormone (LH) (IU/L)
Description
Participants' serum LH levels was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Follicle-stimulating hormone (FSH) (IU/L)
Description
Participants' serum FSH levels was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Total and free (ng/mL)
Description
Participants' serum FSH levels was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Prolactin (ng/mL)
Description
Participants' serum prolactin levels was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)
Description
Participants' serum DHEA-S levels was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Androstenedione (ng/mL)
Description
Participants' serum androstenedione was determined.
Time Frame
change between the first day and the sixth month of the study
Title
17-hydroxyprogesterone (17-OH progesterone) (ng/mL)
Description
Participants' serum 17-OH progesterone was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Sex hormone binding globulin (SHGB) (nmol/L)
Description
Participants' serum SHGB was determined.
Time Frame
change between the first day and the sixth month of the study
Title
Free Androgen Index (FAI)
Description
Free Androgen Index (FAI) was calculated according to the equation FAI = [(Total testosterone/ SHBG) × 100]
Time Frame
change between the first day and the sixth month of the study
Title
The Ferriman-Gallwey score (FGS)
Description
The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.
Time Frame
change between the first day and the sixth month of the study
Title
fasting blood glucose (mg/dl)
Description
Participants' fasting blood gucose was calculated.
Time Frame
change between the first day and the sixth month of the study
Title
fasting insulin (IU/ml)
Description
Participants' fasting insulin was calculated.
Time Frame
change between the first day and the sixth month of the study
Title
HOMA-IR index
Description
Participants' HOMA-IR index value was calculated using the "fasting blood glucose (mmol/L) x fasting insulin (μU/mL)/22.5" formula
Time Frame
change between the first day and the sixth month of the study
Title
QUICKI index
Description
Participants' QUICKI index was calculated using the 1/[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)].
Time Frame
change between the first day and the sixth month of the study
Secondary Outcome Measure Information:
Title
Total cholesterol (mg/dl) composition
Description
Participants' serum total cholesterol was determined.
Time Frame
change between the first day and the sixth month of the study
Title
high-density lipoprotein (HDL-C) (mg/dl)
Description
Participants' serum HDL-C was determined.
Time Frame
change between the first day and the sixth month of the study
Title
low-density lipoprotein (LDL) (mg/dl)
Description
Participants' serum LDL-C was determined.
Time Frame
change between the first day and the sixth month of the study
Title
triglyceride (mg/dl)
Description
Participants' serum triglyceride was determined.
Time Frame
change between the first day and the sixth month of the study
Title
high-sensitivity CRP (HsCRP)(mg/l)
Description
Participants' serum HsCRP was determined.
Time Frame
change between the first day and the sixth month of the study
Title
tumor necrosis factor-alpha (TNF-α) (pg/ml)
Description
Participants' serum TNF-α determined.
Time Frame
change between the first day and the sixth month of the study
Title
interleukin-6 (IL-6) (pg/ml)
Description
Participants' serum IL-6 determined.
Time Frame
change between the first day and the sixth month of the study
Title
Weight in kilograms
Description
Body weight measurement was made.
Time Frame
change between the first day and the sixth month of the study
Title
Height in meters
Description
Height was measured
Time Frame
change between the first day and the sixth month of the study
Title
BMI = body mass index (kg/m2)
Description
BMI = [body weight (kg)/(height [m])2]' was calculated
Time Frame
change between the first day and the sixth month of the study
Title
Neck circumference in cm
Description
Neck circumference was measured
Time Frame
change between the first day and the sixth month of the study
Title
. Waist circumference in cm
Description
waist circumference was measured
Time Frame
change between the first day and the sixth month of the study
Title
body composition analysis
Description
body composition analysis (fat mass /kg), fat percentage (%), fat-free mass (kg)) were made by using the InBody 720 (1-1000 kHz; InBody Co., Ltd. Korea)
Time Frame
change between the first day and the sixth month of the study

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
adolescent girls with obesity and PCOS
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria Age 13-18 years, Body mass index (BMI) ≥ 95th percentile Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rukiye BOZBULUT, Dr
Organizational Affiliation
Gazi Univeristy
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mahmut Orhun Çamurdan, prof
Organizational Affiliation
Gazi University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aysun Bideci, prof
Organizational Affiliation
Gazi University
Official's Role
Study Director
Facility Information:
Facility Name
Esra Döğer
City
Ankara
ZIP/Postal Code
06500
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

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