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Trial Title:
Advanced Glycation End Products and Dietary Intervention in Polycystic Ovary Patients
NCT ID:
NCT05830487
Condition:
Polycystic Ovary Syndrome
Diet Habit
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Conditions: Keywords:
advanced glycation end products
diet
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Low AGE diet with reduced energy and fat
Description:
This group will be given a low AGE diet with reduced energy and fat,.
Arm group label:
Low AGE diet with reduced energy and fat
Intervention type:
Behavioral
Intervention name:
Energy and fat-reduced normal diet
Description:
This group will be given a diet with reduced energy and fat, and AGE levels will not be
interfered with
Arm group label:
Energy and fat-reduced normal diet
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.
Criteria for 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
Gender:
Female
Minimum age:
19 Years
Maximum age:
35 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
hacettepe University
Address:
City:
Ankara
Zip:
06100
Country:
Turkey
Start date:
November 30, 2021
Completion date:
November 2023
Lead sponsor:
Agency:
Hacettepe University
Agency class:
Other
Source:
Hacettepe University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830487
