Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05768724
• Other study ID #: Gazi University Medicine
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: March 2023
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2022
• Est. primary completion date: December 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 13 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diet, Healthy
• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Behavioral:
• intervention diet
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.
• control diet
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

Locations

Country	Name	City	State
Turkey	Esra Döger	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Luteinizing hormone (LH) (IU/L)	Participants' serum LH levels was determined.	change between the first day and the sixth month of the study
Primary	Follicle-stimulating hormone (FSH) (IU/L)	Participants' serum FSH levels was determined.	change between the first day and the sixth month of the study
Primary	Total and free (ng/mL)	Participants' serum FSH levels was determined.	change between the first day and the sixth month of the study
Primary	Prolactin (ng/mL)	Participants' serum prolactin levels was determined.	change between the first day and the sixth month of the study
Primary	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
Primary	Androstenedione (ng/mL)	Participants' serum androstenedione was determined.	change between the first day and the sixth month of the study
Primary	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
Primary	Sex hormone binding globulin (SHGB) (nmol/L)	Participants' serum SHGB was determined.	change between the first day and the sixth month of the study
Primary	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
Primary	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
Primary	fasting blood glucose (mg/dl)	Participants' fasting blood gucose was calculated.	change between the first day and the sixth month of the study
Primary	fasting insulin (IU/ml)	Participants' fasting insulin was calculated.	change between the first day and the sixth month of the study
Primary	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
Primary	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	Total cholesterol (mg/dl) composition	Participants' serum total cholesterol was determined.	change between the first day and the sixth month of the study
Secondary	high-density lipoprotein (HDL-C) (mg/dl)	Participants' serum HDL-C was determined.	change between the first day and the sixth month of the study
Secondary	low-density lipoprotein (LDL) (mg/dl)	Participants' serum LDL-C was determined.	change between the first day and the sixth month of the study
Secondary	triglyceride (mg/dl)	Participants' serum triglyceride was determined.	change between the first day and the sixth month of the study
Secondary	high-sensitivity CRP (HsCRP)(mg/l)	Participants' serum HsCRP was determined.	change between the first day and the sixth month of the study
Secondary	tumor necrosis factor-alpha (TNF-a) (pg/ml)	Participants' serum TNF-a determined.	change between the first day and the sixth month of the study
Secondary	interleukin-6 (IL-6) (pg/ml)	Participants' serum IL-6 determined.	change between the first day and the sixth month of the study
Secondary	Weight in kilograms	Body weight measurement was made.	change between the first day and the sixth month of the study
Secondary	Height in meters	Height was measured	change between the first day and the sixth month of the study
Secondary	BMI = body mass index (kg/m2)	BMI = [body weight (kg)/(height [m])2]' was calculated	change between the first day and the sixth month of the study
Secondary	Neck circumference in cm	Neck circumference was measured	change between the first day and the sixth month of the study
Secondary	. Waist circumference in cm	waist circumference was measured	change between the first day and the sixth month of the study
Secondary	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)	change between the first day and the sixth month of the study