Clinical trial NCT05830487: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Diet Habit
Keywords: advanced glycation end products
diet
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 24
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

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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

Primary outcomes:
measure: Serum advanced glycation end products levels
timeFrame: 12 weeks
measure: Total antioxidant/oxidant capacity
timeFrame: 12 weeks
measure: İnflammation
timeFrame: 12 weeks
measure: Cardio metabolic profile
timeFrame: 12 weeks
measure: Hormonal Profile
timeFrame: 12 weeks
Secondary outcomes:
measure: Body composition
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Body Mass İndex
timeFrame: 12 weeks
measure: Circumference measurements
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: hacettepe University
state: Altindag
Study officials:
affiliation: researcher
name: merve özdemir
role: PRINCIPAL_INVESTIGATOR
References: