PCOS (Polycystic Ovary Syndrome)NCT07124767
The Effects Of Low Insulinemic Index Diet On Overweight And Obese Patients With Polycystic Ovary Syndrome
A study testing 6 weeks of diet with low insulin index diet and 6 weeks of dieting according to TÜBER nutrition recommendations in people with PCOS (Polycystic Ovary Syndrome) and Insulinemic Response, run by Betül Gümüş at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the relationship between PCOS and insulinemic index in overweight and/or obese women with PCOS and to evaluate potential beneficial effects on PCOS. In this study, overweight and obese women with PCOS were divided into two groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome), Insulinemic Response
- What is being tested?
- 6 weeks of diet with low insulin index diet and 6 weeks of dieting according to TÜBER nutrition recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2024to 22 Jul 2025
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Overweight or obese premenopausal women (BMI between 25-49.9 kg/m2),
- Being between 18-45 years of age (childbearing age),
- No underlying metabolic disease (type 2 diabetes, hypertension, undiagnosed anemia, or any other metabolic disease on a special diet).
Who cannot join
- • Pregnancy or breastfeeding within the last 6 months
- Presence of a concomitant disease such as kidney, liver, or heart disease, gout, or hyperuricemia
- Use of medications that affect carbohydrate metabolism (oral contraceptive pills, metformin, antiepileptics, antipsychotics, and glucocorticoids)
- Adherence to special nutrition therapy or a hypocaloric diet in the last three months
- Occasional or current use of medications that may affect fluid balance, including nonsteroidal anti-inflammatory drugs, diuretics, and laxatives
- Deficiencies in biochemical parameters and inability to adhere to the diet were exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atlas University Hospital
Istanbul, Bagcılar, 34408
About this study
Official title: The Effects Of Tüber Low Insulinemic Index And Tüber Healthy Nutrition Recommendations On Overweight And Obese Patients With Polycystic Ovary Syndrome
The aim of this study was to investigate the relationship between PCOS and insulinemic index in overweight and/or obese women with PCOS and to evaluate potential beneficial effects on PCOS. In this study, overweight and obese women with PCOS were divided into two groups. The first group (n=15) received a 6-week nutritional program consisting of low insulin index foods as recommended by TÜBER, while the other group (n=15) received the healthy eating recommendations outlined in TÜBER. Differences in endocrine, metabolic, and anthropometric parameters between these two groups were examined after each 6-week dietary intervention.
Read the detailed description
Research Type, Location, Time, and Sample Selection The aim of this randomised controlled study is to determine the effect of the food insulin index on metabolic (glucose, insulin, C-peptide) and endocrine parameters (LH, FSH, testosterone) as well as anthropometric measurements in overweight and obese women diagnosed with PCOS. In line with this objective, overweight and obese women with PCOS were divided into two groups and followed for 6 weeks; the first group (n=15) was given a diet consisting of foods with a low insulin index selected from the Turkish Nutrition Guide (TÜBER), while the other group (n=15) followed the healthy dietary recommendations outlined in TÜBER. The differences in endocrine, metabolic, and anthropometric parameters between the groups and compared to their baseline values were examined following the diets.
The study population consisted of women who were newly diagnosed with PCOS, met the inclusion criteria, and signed the informed consent form between February 2024 and February 2025 at the Atlas University Medicine Hospital's gynaecology and obstetrics clinic, following ethical committee approval. Approval for the study was obtained from the Clinical Ethics Committee of Istanbul Cerrahpaşa University, and the study was conducted in accordance with the ethical principles of the Helsinki Declaration. The purpose of the study was clearly explained to all participants, and written informed consent forms were obtained. Participants in groups 1 and 2 completed a general information form, underwent anthropometric measurements, and had their biochemical measurements recorded. Biochemical measurements obtained from patients and found in their files were transferred to the researcher's biochemical parameters form. Interviews with patients were conducted at the hospital's diet clinic.
The study was conducted with 30 overweight or obese PCOS patients. The first group, consisting of 15 patients, completed the study with a nutrition programme consisting of foods with a low insulin index according to TÜBER, while the second group, consisting of 15 patients, completed the study by applying the healthy nutrition principles specified in TÜBER.
General Plan of the Study Patients who visited the Gynaecology and Obstetrics Outpatient Clinic of Atlas University Medicine Hospital, were diagnosed with PCOS, met the inclusion criteria. Anthropometric measurements (height, waist circumference, and body composition) were taken by the researcher, and a 24-hour dietary record was recorded by a dietitian using a reminder method. The physical activity questionnaire was completed by the researcher, portion sizes of foods were explained using visuals and replicas, and biochemical parameters were obtained from patient files and processed into biochemical parameters.
Nutrition plans were prepared by the dietitian and explained to the patients based on anthropometric measurements, physical activity status, food consumption records, and biochemical parameters, and the patients were randomly assigned to a diet group (TÜBER Low Insulinemic Index and TÜBER Healthy Nutrition Recommendations) without knowing which group they were in. Patients were monitored weekly for six weeks, and they were asked to keep a 24-hour food consumption record, with macro and micro nutrient intake recorded based on the food consumption record.
- Being tested
- 6 weeks of diet with low insulin index diet, 6 weeks of dieting according to TÜBER nutrition recommendations
- Keywords
- PCOS, Food insulinemic index, Türkiye nutrition guidelines
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 weeks of diet with low insulin index dietOther
6 weeks diet period for the low insulin index group. this group has a diet programme assigned by the conductor dietitian.
6 weeks of dieting according to TÜBER nutrition recommendationsOther
6 weeks of diet according to the TÜBER recomendations were applied to this group. Diets were assigned by the conductor dietitian.
| Study group | Role | What they receive |
|---|---|---|
| tüber diet group | Active comparator | Tüber diet group consists of 15 people. These patients of PCOS had a diet intervention according to Turkiye nutrition guidelines for 6 weeks period. Receives: Other: 6 weeks of dieting according to TÜBER nutrition recommendations |
| low food insulin index group | Active comparator | low food insulin index group consists of 15 people. These patients of PCOS had a diet intervention with food selected according to their insulin indexes for 6 weeks period. Receives: Other: 6 weeks of diet with low insulin index diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric measurements
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, Anthropometric measurements were evaluated, measured and compared. Anthropometric measurements used for determination of BMI kg/m^2. BMI was determined according to world health organization guides, Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
Measured: From enrollment to the end of treatment at 6 weeks
physical activity status
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, physical activity status were evaluated, measured and compared. Physical activity of participants were questioned by using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), participants were classified as sedandery, normal, active. Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
Measured: beginning and end of the 6-week diet periods
food consumption
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, food consumption records were evaluated, measured and compared. food consumption record was taken according to FAO guidelines. it was evaluated for its calories.
Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
Measured: beginning and end of the 6-week diet periods.
biochemical parameters
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, biochemical parameters were evaluated, measured and compared. glucose and insulin scores were used to determine the HOMA IR. Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
Measured: beginning and end of the 6-week diet periods.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start28 Jun 2024
- Primary completion20 May 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized single blind two group study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Betül Gümüş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Betül Gümüş, Atlas University
- Investigators
- betül gümüş, masters, Principal investigator, Atlas University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07124767
- Sponsor's protocol ID
- 28.06.2024-993352
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Tüber Low Insulinemic Index And Tüber Healthy Nutrition Recommendations On Overweight And Obese Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT07124767
- Acronym / sponsor ID
- 28.06.2024-993352
- Keywords
- PCOS, Food insulinemic index, Türkiye nutrition guidelines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Betül GümüşUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 20 May 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 15 Aug 2025 (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.
The aim of this study was to investigate the relationship between PCOS and insulinemic index in overweight and/or obese women with PCOS and to evaluate potential beneficial effects on PCOS. In this study, overweight and obese women with PCOS were divided into two groups. The first group (n=15) received a 6-week nutritional program consisting of low insulin index foods as recommended by TÜBER, while the other group (n=15) received the healthy eating recommendations outlined in TÜBER. Differences in endocrine, metabolic, and anthropometric parameters between these two groups were examined after each 6-week dietary intervention.
Detailed description
Research Type, Location, Time, and Sample Selection The aim of this randomised controlled study is to determine the effect of the food insulin index on metabolic (glucose, insulin, C-peptide) and endocrine parameters (LH, FSH, testosterone) as well as anthropometric measurements in overweight and obese women diagnosed with PCOS. In line with this objective, overweight and obese women with PCOS were divided into two groups and followed for 6 weeks; the first group (n=15) was given a diet consisting of foods with a low insulin index selected from the Turkish Nutrition Guide (TÜBER), while the other group (n=15) followed the healthy dietary recommendations outlined in TÜBER. The differences in endocrine, metabolic, and anthropometric parameters between the groups and compared to their baseline values were examined following the diets.
The study population consisted of women who were newly diagnosed with PCOS, met the inclusion criteria, and signed the informed consent form between February 2024 and February 2025 at the Atlas University Medicine Hospital's gynaecology and obstetrics clinic, following ethical committee approval. Approval for the study was obtained from the Clinical Ethics Committee of Istanbul Cerrahpaşa University, and the study was conducted in accordance with the ethical principles of the Helsinki Declaration. The purpose of the study was clearly explained to all participants, and written informed consent forms were obtained. Participants in groups 1 and 2 completed a general information form, underwent anthropometric measurements, and had their biochemical measurements recorded. Biochemical measurements obtained from patients and found in their files were transferred to the researcher's biochemical parameters form. Interviews with patients were conducted at the hospital's diet clinic.
The study was conducted with 30 overweight or obese PCOS patients. The first group, consisting of 15 patients, completed the study with a nutrition programme consisting of foods with a low insulin index according to TÜBER, while the second group, consisting of 15 patients, completed the study by applying the healthy nutrition principles specified in TÜBER.
General Plan of the Study Patients who visited the Gynaecology and Obstetrics Outpatient Clinic of Atlas University Medicine Hospital, were diagnosed with PCOS, met the inclusion criteria. Anthropometric measurements (height, waist circumference, and body composition) were taken by the researcher, and a 24-hour dietary record was recorded by a dietitian using a reminder method. The physical activity questionnaire was completed by the researcher, portion sizes of foods were explained using visuals and replicas, and biochemical parameters were obtained from patient files and processed into biochemical parameters.
Nutrition plans were prepared by the dietitian and explained to the patients based on anthropometric measurements, physical activity status, food consumption records, and biochemical parameters, and the patients were randomly assigned to a diet group (TÜBER Low Insulinemic Index and TÜBER Healthy Nutrition Recommendations) without knowing which group they were in. Patients were monitored weekly for six weeks, and they were asked to keep a 24-hour food consumption record, with macro and micro nutrient intake recorded based on the food consumption record.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized single blind two group study
| Arm | Type | Receives |
|---|---|---|
| tüber diet group | Active comparator | Other: 6 weeks of dieting according to TÜBER nutrition recommendationsTüber diet group consists of 15 people. These patients of PCOS had a diet intervention according to Turkiye nutrition guidelines for 6 weeks period. |
| low food insulin index group | Active comparator | Other: 6 weeks of diet with low insulin index dietlow food insulin index group consists of 15 people. These patients of PCOS had a diet intervention with food selected according to their insulin indexes for 6 weeks period. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Overweight or obese premenopausal women (BMI between 25-49.9 kg/m2),
- Being between 18-45 years of age (childbearing age),
- No underlying metabolic disease (type 2 diabetes, hypertension, undiagnosed anemia, or any other metabolic disease on a special diet).
Key exclusion criteria (6 listed)
- • Pregnancy or breastfeeding within the last 6 months
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 |
|---|---|---|
| 6 weeks of diet with low insulin index diet6 weeks diet period for the low insulin index group. this group has a diet programme assigned by the conductor dietitian. | Other | low food insulin index group |
| 6 weeks of dieting according to TÜBER nutrition recommendations6 weeks of diet according to the TÜBER recomendations were applied to this group. Diets were assigned by the conductor dietitian. | Other | tüber diet group |
Primary outcome
Anthropometric measurements
Time frame: From enrollment to the end of treatment at 6 weeks
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, Anthropometric measurements were evaluated, measured and compared. Anthropometric measurements used for determination of BMI kg/m^2. BMI was determined according to world health organization guides, Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
physical activity status
Time frame: beginning and end of the 6-week diet periods
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, physical activity status were evaluated, measured and compared. Physical activity of participants were questioned by using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), participants were classified as sedandery, normal, active. Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
food consumption
Time frame: beginning and end of the 6-week diet periods.
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, food consumption records were evaluated, measured and compared. food consumption record was taken according to FAO guidelines. it was evaluated for its calories. Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
biochemical parameters
Time frame: beginning and end of the 6-week diet periods.
for two groups; TÜBER nutrition recommendations diet and low insulin index diet, biochemical parameters were evaluated, measured and compared. glucose and insulin scores were used to determine the HOMA IR. Comparisons were made between the beginning and end of the 6-week diet periods. IBM SPSS statistics programme was used for the comparisons.
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 15 Aug 2025.
Related trials for PCOS (Polycystic Ovary Syndrome)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
betül gümüş, masters principal investigator
Atlas University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 weeks of diet with low insulin index diet and 6 weeks of dieting according to TÜBER nutrition recommendations in people with PCOS (Polycystic Ovary Syndrome) and Insulinemic Response, run by Betül Gümüş 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 6 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 15 Aug 2025. 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?
Anthropometric measurements (time frame: From enrollment to the end of treatment at 6 weeks). The study lists 4 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 15 Aug 2025.