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Completed

NCT Number: NCT07124767

The Effects Of Low Insulinemic Index Diet 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlas University Hospital

Istanbul, Bagcılar, 34408, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • • 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.

Treatment and study plan

6 weeks of diet with low insulin index diet

Other

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 recommendations

Other

6 weeks of diet according to the TÜBER recomendations were applied to this group. Diets were assigned by the conductor dietitian.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Betül Gümüş

Other

Registry information

Official study title

The Effects Of Tüber Low Insulinemic Index And Tüber Healthy Nutrition Recommendations On Overweight And Obese Patients With Polycystic Ovary Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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