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Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients

H

Hacettepe University

Status

Invitation-only

Conditions

Diet Habit
Polycystic Ovary Syndrome

Treatments

Behavioral: Energy and fat-reduced normal diet
Behavioral: Low AGE diet with reduced energy and fat

Study type

Interventional

Funder types

Other

Identifiers

NCT05830487
HACETTEPE UNIVERSITY-OZDEMIR-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

Female

Ages

19 to 35 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Low AGE diet with reduced energy and fat
Experimental group
Description:
Low advanced glycation end products diet with reduced energy and fat
Treatment:
Behavioral: Low AGE diet with reduced energy and fat
Energy and fat-reduced normal diet
Experimental group
Description:
only energy and fat-reduced diet, advanced glycation end products intake will not be interfered with.
Treatment:
Behavioral: Energy and fat-reduced normal diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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