Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

Effect of Dietary Intervention on Serum Advanced Glycation End Products and Metabolic Profile in Polycystic Ovary Syndrome Patients

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Polycystic Ovary Syndrome; Diet Habit
• Intervention / Treatment: Behavioral: Low AGE diet with reduced energy and fat; Behavioral: Energy and fat-reduced normal diet

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:• Being diagnosed with PCOS Being between the ages of 19-35 Having a body mass index of more than 25 kg/m2 Volunteering to work

-

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low AGE diet with reduced energy and fat; Low advanced glycation end products diet with reduced energy and fat	Behavioral: Low AGE diet with reduced energy and fat; This group will be given a low AGE diet with reduced energy and fat,.
Experimental: Energy and fat-reduced normal diet; only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum advanced glycation end products levels	The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention	12 weeks
Total antioxidant/oxidant capacity	The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention	12 weeks
İnflammation	The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention	12 weeks
Cardio metabolic profile	The comparison of fasting insulin (mg/dL), fasting blood sugar (mg/dL), lipid parameters (triglyceride (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), total cholesterol (mg/dL)) values of 24 patients at baseline and week 12.	12 weeks
Hormonal Profile	From hormonal indicators total testosterone (ng/mL), sex hormone-binding globulin ng/mL) , Anti mullerian hormone (ng/mL) values of 24 patients at baseline and week 12 will be compared.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	The comparison of body fat percentage of 24 patients at baseline and week 12	12 weeks
Body weight	The comparison of body weight (kg) of 24 patients at baseline and week 12	12 weeks
Body Mass İndex	Body mass index (kg/m^2) of 24 patients at baseline and week 12 will be compared	12 weeks
Circumference measurements	waist circumference (cm) and hip circumference (cm) of 24 patients at baseline and week 12 will be compared	12 weeks

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: merve özdemir, Researcher

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: diet; advanced glycation end products
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: HACETTEPE UNIVERSITY-OZDEMIR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No