Effect of Mediterranean Diet Supplemented With Aronia and Low-Fat Diet on Hepatic Steatosis, Inflammation, Oxidative Stress and Microbiota in Non-alcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
- 主要终点
- Oxidative stress
研究概览
简要总结
Adults newly diagnosed with NAFLD will be included in the study. At the beginning of the research, the socio-demographic characteristics and nutritional habits of the individuals will be questioned with a face-to-face questionnaire. In addition, at the beginning of the study, blood samples, 3-day food consumption record, physical activity record, anthropometric measurements (height, body weight, waist, hip and neck circumference and body composition analysis) and stool samples will be taken from the patients. Oxidative stress (TAS, TOS, SOD, Malondialdehyde, Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage) and inflammation (CRP, TNF-alpha, IL-17, IL-23, IL-10, IL-13, TGF-beta) parameters in blood samples will be analyzed. Patients will then be randomized into four groups to follow a Mediterranean diet supplemented with aronia, a Mediterranean diet, a low-fat diet supplemented with aronia, or a low-fat diet. Necessary training will be given to the participants so that they can apply the individually planned diet. Dietary adherence and anthropometric measurements will be evaluated every 2 weeks. At the end of the twelve-week follow-up, all parameters evaluated at the beginning of the study will be repeated and compared with previous values.
详细描述
Non-alcoholic fatty liver disease (NAFLD) is a chronic liver disease in which more than 5% fat accumulation in the liver (steatosis). It has become the most common liver disease in adults with the effect of obesity. In fact, NAFLD is seen in approximately 25% of adults. If left untreated, it can progress to cirrhosis, hepatocellular carcinoma, and end-stage liver failure. It is obvious that it is necessary to identify preventive factors for NAFLD and to develop new approaches for its treatment. There is an increase in inflammation and oxidative stress levels in NAFLD, which is important for the development of possible treatment methods. In this study, the Mediterranean diet supplemented with aronia is expected to contribute positively to progression of the disease by improving inflammation and oxidative stress parameters. Adding aronia to the Mediterranean diet will increase the polyphenol content of this diet. This study was planned with the thought that a Mediterranean diet supplemented with aronia will have positive effects on hepatic steatosis, oxidative stress, inflammation, and microbiota in NAFLD, where lifestyle changes, including healthy nutrition, are included in the primary treatment.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18- 64 years of age
- •Body mass index (BMI) 25-40 kg/m2
- •Newly diagnosed with NAFLD and has not been treated before
- •Volunteering
排除标准
- •Chronic disease other than NAFLD
- •Pregnancy or breastfeeding
- •Bleeding disorder
- •Regular medication use
- •Any food allergies or intolerances
- •Being on a special diet treatment
- •Smoking in the last year
- •Alcohol use in the last year
- •Having used antibiotics in the last 3 months
- •Use of prebiotics or probiotics in the last 3 months
- •Use of proton pump inhibitors in the last 3 months
- •Use of vitamin-mineral supplementation in the last 3 months
- •Use of nutritional supplements in the last 3 months
结局指标
主要结局
Oxidative stress
时间窗: Baseline and end of the 12th week
TAS, TOS, SOD, Malondialdehyde (MDA), Catalase, Glutathione peroxidase, Glutathione, AGE and DNA oxidative damage will be evaluated.
Microbiota analysis
时间窗: Baseline and end of the 12th week
16s rRNA Gene Sequencing and Compositional Analyzes
Body composition analysis
时间窗: Baseline, every 15 days and end of the 12th week
Body weight, height and body composition, waist, hip and neck circumference measurements
Inflammation
时间窗: Baseline and end of the 12th week
CRP, TNF-alfa, IL-10, IL-13, IL-17, IL-23, TGF-β, LPS will be evaluated.
Degree of hepatic steatosis
时间窗: Baseline and end of the 12th week
Evaluation of hepatic steatosis by liver ultrasonography
次要结局
未报告次要终点
研究者
Gamze Akbulut
Professor Doctor
Istanbul Kent University