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Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

Primary Purpose

Polycystic Ovary Syndrome, Diet Habit

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low AGE diet with reduced energy and fat
Energy and fat-reduced normal diet
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Polycystic Ovary Syndrome focused on measuring advanced glycation end products, diet

Eligibility Criteria

19 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • hacettepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low AGE diet with reduced energy and fat

Energy and fat-reduced normal diet

Arm Description

Low advanced glycation end products diet with reduced energy and fat

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

Outcomes

Primary Outcome Measures

Serum advanced glycation end products levels
The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention
Total antioxidant/oxidant capacity
The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention
İnflammation
The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
January 25, 2023
Last Updated
April 24, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05830487
Brief Title
Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients
Official Title
Effect of Dietary Intervention on Serum Advanced Glycation End Products and Metabolic Profile in Polycystic Ovary Syndrome Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Diet Habit
Keywords
advanced glycation end products, diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low AGE diet with reduced energy and fat
Arm Type
Experimental
Arm Description
Low advanced glycation end products diet with reduced energy and fat
Arm Title
Energy and fat-reduced normal diet
Arm Type
Experimental
Arm Description
only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with.
Intervention Type
Behavioral
Intervention Name(s)
Low AGE diet with reduced energy and fat
Intervention Description
This group will be given a low AGE diet with reduced energy and fat,.
Intervention Type
Behavioral
Intervention Name(s)
Energy and fat-reduced normal diet
Intervention Description
This group will be given a diet with reduced energy and fat, and AGE levels will not be interfered with
Primary Outcome Measure Information:
Title
Serum advanced glycation end products levels
Description
The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention
Time Frame
12 weeks
Title
Total antioxidant/oxidant capacity
Description
The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention
Time Frame
12 weeks
Title
İnflammation
Description
The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention
Time Frame
12 weeks
Title
Cardio metabolic profile
Description
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.
Time Frame
12 weeks
Title
Hormonal Profile
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body composition
Description
The comparison of body fat percentage of 24 patients at baseline and week 12
Time Frame
12 weeks
Title
Body weight
Description
The comparison of body weight (kg) of 24 patients at baseline and week 12
Time Frame
12 weeks
Title
Body Mass İndex
Description
Body mass index (kg/m^2) of 24 patients at baseline and week 12 will be compared
Time Frame
12 weeks
Title
Circumference measurements
Description
waist circumference (cm) and hip circumference (cm) of 24 patients at baseline and week 12 will be compared
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
merve özdemir
Organizational Affiliation
researcher
Official's Role
Principal Investigator
Facility Information:
Facility Name
hacettepe University
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

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