Polycystic Ovary SyndromeNCT05768724
Two Different Dietary Interventions for Girls With Polycystic Ovary Syndrome
A study testing intervention diet in people with Polycystic Ovary Syndrome and Obesity, run by Gazi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Obesity, Androgen; Hypersecretion
- What is being tested?
- intervention diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria
- Age 13-18 years,
- Body mass index (BMI) ≥ 95th percentile
Who cannot join
- 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
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- Contraceptive use in the last 3 months
- Use of insulin-sensitizing agents
- Use of drugs affecting lipid metabolism (such as fish oil)
- Smoking.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- intervention diet, control diet
- Medical subject headings
- Polycystic Ovary Syndrome, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention dietBehavioural
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 dietBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| İntervention group | Experimental | METAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS Receives: Behavioral: intervention diet |
| conrol group | Experimental | American Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS Receives: Behavioral: control diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Luteinizing hormone (LH) (IU/L)
Participants' serum LH levels was determined.
Measured: change between the first day and the sixth month of the study
Follicle-stimulating hormone (FSH) (IU/L)
Participants' serum FSH levels was determined.
Measured: change between the first day and the sixth month of the study
Total and free (ng/mL)
Participants' serum FSH levels was determined.
Measured: change between the first day and the sixth month of the study
Prolactin (ng/mL)
Participants' serum prolactin levels was determined.
Measured: 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.
Measured: change between the first day and the sixth month of the study
Androstenedione (ng/mL)
Participants' serum androstenedione was determined.
Measured: 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.
Measured: change between the first day and the sixth month of the study
Sex hormone binding globulin (SHGB) (nmol/L)
Participants' serum SHGB was determined.
Measured: 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]
Measured: 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.
Measured: change between the first day and the sixth month of the study
fasting blood glucose (mg/dl)
Participants' fasting blood gucose was calculated.
Measured: change between the first day and the sixth month of the study
fasting insulin (IU/ml)
Participants' fasting insulin was calculated.
Measured: 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
Measured: 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)].
Measured: change between the first day and the sixth month of the study
Secondary outcomes (13)
Total cholesterol (mg/dl) composition
Participants' serum total cholesterol was determined.
Measured: change between the first day and the sixth month of the study
high-density lipoprotein (HDL-C) (mg/dl)
Participants' serum HDL-C was determined.
Measured: change between the first day and the sixth month of the study
low-density lipoprotein (LDL) (mg/dl)
Participants' serum LDL-C was determined.
Measured: change between the first day and the sixth month of the study
triglyceride (mg/dl)
Participants' serum triglyceride was determined.
Measured: change between the first day and the sixth month of the study
high-sensitivity CRP (HsCRP)(mg/l)
Participants' serum HsCRP was determined.
Measured: change between the first day and the sixth month of the study
tumor necrosis factor-alpha (TNF-α) (pg/ml)
Participants' serum TNF-α determined.
Measured: change between the first day and the sixth month of the study
interleukin-6 (IL-6) (pg/ml)
Participants' serum IL-6 determined.
Measured: change between the first day and the sixth month of the study
Weight in kilograms
Body weight measurement was made.
Measured: change between the first day and the sixth month of the study
Height in meters
Height was measured
Measured: change between the first day and the sixth month of the study
BMI = body mass index (kg/m2)
BMI = [body weight (kg)/(height [m])2]' was calculated
Measured: change between the first day and the sixth month of the study
Neck circumference in cm
Neck circumference was measured
Measured: change between the first day and the sixth month of the study
. Waist circumference in cm
waist circumference was measured
Measured: change between the first day and the sixth month of the study
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)
Measured: change between the first day and the sixth month of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jan 2021
- Primary completion5 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-blind, randomized, two-arm, parallel six-month dietary intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Döğer, Gazi University
- Investigators
- Rukiye BOZBULUT, Dr, Study chair, Gazi UniveristyMahmut Orhun Çamurdan, prof, Study chair, Gazi UniversityAysun Bideci, prof, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768724
- Sponsor's protocol ID
- Gazi University Medicine
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05768724
- Acronym / sponsor ID
- Gazi University Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-blind, randomized, two-arm, parallel six-month dietary intervention.
| Arm | Type | Receives |
|---|---|---|
| İntervention group | Experimental | Behavioral: intervention dietMETAbolic Syndrome REduction in NAvarra (RESMENA) diet was applied to adolescents with PCOS |
| conrol group | Experimental | Behavioral: control dietAmerican Heart Association (AHA) guidelines based diet was applied to adolescents with PCOS |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of PCOS in adolescent girls according to the Rotterdam criteria
- Age 13-18 years,
- Body mass index (BMI) ≥ 95th percentile
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intervention dietThe 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. | Behavioural | İntervention group |
| control dietControl 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 | Behavioural | conrol group |
Primary outcome
Luteinizing hormone (LH) (IU/L)
Time frame: change between the first day and the sixth month of the study
Participants' serum LH levels was determined.
Follicle-stimulating hormone (FSH) (IU/L)
Time frame: change between the first day and the sixth month of the study
Participants' serum FSH levels was determined.
Total and free (ng/mL)
Time frame: change between the first day and the sixth month of the study
Participants' serum FSH levels was determined.
Prolactin (ng/mL)
Time frame: change between the first day and the sixth month of the study
Participants' serum prolactin levels was determined.
Dehydroepiandrosterone sulfate (DHEA-S) (µg/dL)
Time frame: change between the first day and the sixth month of the study
Participants' serum DHEA-S levels was determined.
Androstenedione (ng/mL)
Time frame: change between the first day and the sixth month of the study
Participants' serum androstenedione was determined.
17-hydroxyprogesterone (17-OH progesterone) (ng/mL)
Time frame: change between the first day and the sixth month of the study
Participants' serum 17-OH progesterone was determined.
Sex hormone binding globulin (SHGB) (nmol/L)
Time frame: change between the first day and the sixth month of the study
Participants' serum SHGB was determined.
Free Androgen Index (FAI)
Time frame: change between the first day and the sixth month of the study
Free Androgen Index (FAI) was calculated according to the equation FAI = [(Total testosterone/ SHBG) × 100]
The Ferriman-Gallwey score (FGS)
Time frame: change between the first day and the sixth month of the study
The Ferriman-Gallwey score (FGS) was used to evaluate hirsutism.
fasting blood glucose (mg/dl)
Time frame: change between the first day and the sixth month of the study
Participants' fasting blood gucose was calculated.
fasting insulin (IU/ml)
Time frame: change between the first day and the sixth month of the study
Participants' fasting insulin was calculated.
HOMA-IR index
Time frame: change between the first day and the sixth month of the study
Participants' HOMA-IR index value was calculated using the "fasting blood glucose (mmol/L) x fasting insulin (μU/mL)/22.5" formula
QUICKI index
Time frame: change between the first day and the sixth month of the study
Participants' QUICKI index was calculated using the 1/[log(fasting insulin in μU/ml)+log(fasting glucose in mg/dl)].
13 secondary outcomes
Total cholesterol (mg/dl) composition
Time frame: change between the first day and the sixth month of the study
high-density lipoprotein (HDL-C) (mg/dl)
Time frame: change between the first day and the sixth month of the study
low-density lipoprotein (LDL) (mg/dl)
Time frame: change between the first day and the sixth month of the study
triglyceride (mg/dl)
Time frame: change between the first day and the sixth month of the study
high-sensitivity CRP (HsCRP)(mg/l)
Time frame: change between the first day and the sixth month of the study
tumor necrosis factor-alpha (TNF-α) (pg/ml)
Time frame: change between the first day and the sixth month of the study
interleukin-6 (IL-6) (pg/ml)
Time frame: change between the first day and the sixth month of the study
Weight in kilograms
Time frame: change between the first day and the sixth month of the study
Height in meters
Time frame: change between the first day and the sixth month of the study
BMI = body mass index (kg/m2)
Time frame: change between the first day and the sixth month of the study
Neck circumference in cm
Time frame: change between the first day and the sixth month of the study
. Waist circumference in cm
Time frame: change between the first day and the sixth month of the study
body composition analysis
Time frame: change between the first day and the sixth month of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rukiye BOZBULUT, Dr study chair
Gazi Univeristy
Mahmut Orhun Çamurdan, prof study chair
Gazi University
Aysun Bideci, prof study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention diet in people with Polycystic Ovary Syndrome and Obesity, run by Gazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Luteinizing hormone (LH) (IU/L) (time frame: change between the first day and the sixth month of the study). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.