Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05830487
• Other study ID #: HACETTEPE UNIVERSITY-OZDEMIR-1
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 30, 2021
• Est. completion date: November 2023

Study information

• Verified date: April 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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

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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

Related Conditions & MeSH terms

• Diet Habit
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	hacettepe University	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Total antioxidant/oxidant capacity	The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention	12 weeks
Primary	Inflammation	The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention	12 weeks
Primary	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
Primary	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	Body composition	The comparison of body fat percentage of 24 patients at baseline and week 12	12 weeks
Secondary	Body weight	The comparison of body weight (kg) of 24 patients at baseline and week 12	12 weeks
Secondary	Body Mass Index	Body mass index (kg/m^2) of 24 patients at baseline and week 12 will be compared	12 weeks
Secondary	Circumference measurements	waist circumference (cm) and hip circumference (cm) of 24 patients at baseline and week 12 will be compared	12 weeks