The Effects Of Low Insulinemic Index Diet On Overweight And Obese Patients With Polycystic Ovary Syndrome

NCT ID: NCT07124767

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-28
• Study Completion Date: 2025-07-22

Brief 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. 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.

Conditions

PCOS (Polycystic Ovary Syndrome); Insulinemic Response

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

tüber diet group

Tüber diet group consists of 15 people. These patients of PCOS had a diet intervention according to Turkiye nutrition guidelines for 6 weeks period.

Group Type: ACTIVE_COMPARATOR

6 weeks of dieting according to TÜBER nutrition recommendations

Intervention Type: OTHER

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

low food insulin index group

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.

Group Type: ACTIVE_COMPARATOR

6 weeks of diet with low insulin index diet

Intervention Type: OTHER

6 weeks diet period for the low insulin index group. this group has a diet programme assigned by the conductor dietitian.

Interventions

6 weeks of diet with low insulin index diet

6 weeks diet period for the low insulin index group. this group has a diet programme assigned by the conductor dietitian.

Intervention Type: OTHER

6 weeks of dieting according to TÜBER nutrition recommendations

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Betül Gümüş

OTHER

Sponsor Role: lead

Responsible Party

Betül Gümüş

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

betül gümüş, masters

Role: PRINCIPAL_INVESTIGATOR

Atlas University Hospital

Locations

Atlas University Hospital

Istanbul, Bagcılar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

28.06.2024-993352

Identifier Type: -

Identifier Source: org_study_id