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

NCT07124767 | Completed DMC

• 1 other identifier: 28.06.2024-993352
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS (Polycystic Ovary Syndrome); Insulinemic Response

Keywords

PCOS; Food insulinemic index; Türkiye nutrition guidelines

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  beginning and end of the 6-week diet periods.

Study Arms (2)

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.

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.

Other: 6 weeks of diet with low insulin index diet

Interventions

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.

low food insulin index group

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.

tüber diet group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Betül Gümüş: lead

Study Sites (1)

Atlas University Hospital

Istanbul, Bagcılar, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Diet

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• betül gümüş, masters

  Atlas University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: randomized single blind two group study

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: August 15, 2025
• Study Start: June 28, 2024
• Primary Completion: May 20, 2025
• Study Completion: July 22, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

TU (1)