Effect of Dietary Intervention on Serum Advanced Glycation End Products and Metabolic Profile in Polycystic Ovary Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Total antioxidant/oxidant capacity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Total antioxidant/oxidant capacity
时间窗: 12 weeks
The comparison total antioxidant/oxidant capacity levels of 24 patients before and after dietary intervention
Serum advanced glycation end products levels
时间窗: 12 weeks
The comparison of serum advanced glycation end products levels of 24 patients before and after dietary intervention
Cardio metabolic profile
时间窗: 12 weeks
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.
İnflammation
时间窗: 12 weeks
The comparison tnf-a and hs-CRP levels of 24 patients before and after dietary intervention
Hormonal Profile
时间窗: 12 weeks
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.
次要结局
- Body composition(12 weeks)
- Body Mass İndex(12 weeks)
- Circumference measurements(12 weeks)
- Body weight(12 weeks)
研究者
Merve Özdemir
Research Assistant
Hacettepe University