Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

NCT ID: NCT05830487

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2023-11-30

Brief Summary

Recently, the negative effects of advanced glycation end products on the pathophysiology of some diseases have attracted attention. This study was planned to evaluate the effect of dietary intervention and weight loss on serum advanced glycation and disease pathogenesis in patients with polycystic ovary syndrome.

Detailed Description

The significantly increased consumption of processed foods in recent years has also increased the amount of sugar and fat in the diet. These changes in dietary habits also increase exposure to advanced glycation end products. Advanced glycation end products (AGEs) are the products occurred as a result of the Maillard reaction by the combination of the carbonyl group of carbohydrates and the free amino groups of amino acids. Advance glycation end products causes irreversible cross-linking of proteins, resulting in loss of protein structure and function. Advanced glycation end products formation is a slow process in normal conditions, but chronic diseases such as diabetes, insulin resistance, aging, oxidative stress and PCOS accelerate the occurrence of endogenous AGEs.

Polycystic ovary syndrome (PCOS) is an endocrine disorder that is characterized by hyperandrogenism, oligo/anovulation and polycystic ovaries and it affects up to 25% of reproductive-aged women. Women with PCOS have been shown to have an increase in the levels of AGEs in the bloodstream and the expression of proinflammatory receptors of AGEs in the ovaries, such as RAGE. In addition, the levels of protective anti-inflammatory receptors called soluble receptors for advanced glycation end products (sRAGE) were found to be low in women with PCOS. Patient with PCOS in particular have high levels of serum AGEs, regardless of their body weight or the presence of insulin resistance.

In this project, aimed to investigate effect of a diet with reduced energy and fat content and a low AGE diet with reduced energy and fat content for 12 weeks in overweight and obese individuals with polycystic ovary syndrome.

Body composition, anthropometric measurements, serum AGE levels, serum antioxidant capacity, inflammation, cardio metabolic profile, hormonal profile, and also Anti-Mullerian Hormone (AMH) values will be examined in individuals and the results will be evaluated by comparing diet groups. Volunteers participating in the study will apply one of two different dietary treatments to be determined by stratified randomization method for 12 weeks. The smallest sample size was calculated as a total of 24 patients, 12 patients in each intervention group, taking into account the change in serum AGE value at 80% power and 95% confidence intervals.

Conditions

Polycystic Ovary Syndrome; Diet Habit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Low AGE diet with reduced energy and fat

Low advanced glycation end products diet with reduced energy and fat

Group Type: EXPERIMENTAL

Low AGE diet with reduced energy and fat

Intervention Type: BEHAVIORAL

This group will be given a low AGE diet with reduced energy and fat,.

Energy and fat-reduced normal diet

only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with.

Group Type: EXPERIMENTAL

Energy and fat-reduced normal diet

Intervention Type: BEHAVIORAL

This group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with

Interventions

Low AGE diet with reduced energy and fat

This group will be given a low AGE diet with reduced energy and fat,.

Intervention Type: BEHAVIORAL

Energy and fat-reduced normal diet

This group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• Presence of chronic disease (Diabetes, Hypertension, Atherosclerotic heart diseases, gastrointestinal system diseases..)

• Being in pregnancy-lactation or menopause period
• Using oral contraceptive medication
• Using vitamin-mineral support
• Receiving a special dietary treatment
• To have applied a weight loss diet in the last 3 months
• To smoke

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Merve Özdemir

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

merve özdemir

Role: PRINCIPAL_INVESTIGATOR

researcher

Locations

hacettepe University

Ankara, Altindag, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Ozdemir M, Mumusoglu S, Bilgic P. Comparison of Metabolic and Hormonal Profiles between Low-Advanced Glycation End Products (AGEs) and Standard AGEs-Containing Weight-Loss Diets in Overweight Phenotype-A PCOS Patients: A Randomized Clinical Trial. Reprod Sci. 2025 Apr;32(4):1190-1201. doi: 10.1007/s43032-025-01808-8. Epub 2025 Feb 14.

Reference Type: DERIVED

PMID: 39953370 (View on PubMed)

Other Identifiers

HACETTEPE UNIVERSITY-OZDEMIR-1

Identifier Type: -

Identifier Source: org_study_id