The Effect of Mediterranean Diet and Low Fat Diet on Hepatic Fat, Inflammation and Oxidative Stress in Obese Adolescents With Nonalcoholic Fatty Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Changes in glycemic profile
研究概览
简要总结
The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.
详细描述
This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver disease (NAFLD). The study, which was designed as a single blind randomized control, was completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18. Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week, adolescents' blood samples, physical activity and food consumption records were taken, anthropometric measurements and body composition analyzes were made, and antioxidant food consumption frequency and Mediterranean diet quality index questionnaire were applied to adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the physical activity and food consumption records of the adolescents were repeated and anthropometric measurements and body composition analyzes were made again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 11-18
- •Being obese (BMI ≥95.persentil)
- •Getting a diagnosis of Grade≥1 NAFLD
排除标准
- •Existence of liver disease (wilson,hepatitis etc.) other than NAFLD
- •Drinking alcohol
- •Having a history of type 1 and type 2 diabetes
- •Using drugs that can cause steatosis
- •Using lipid-lowering drugs
- •Using weight loss medications
- •Having applied dietary therapy for any disease and weight loss
- •Existence of a chronic inflammatory disease
- •Existence of cancer
- •Thyroid dysfunction (hyperthyroid and hypothyroidism)
- •Existence of a history of hepatic virus infection
- •Having a history of parenteral nutrition
- •Being pregnant and breastfeeding
- •Receiving antibiotic treatment within 3 months prior to the study
- •Regularly consuming foods containing probiotic and prebiotic properties and / or using nutritional supplements
结局指标
主要结局
Changes in glycemic profile
时间窗: Baseline and week 12
Measurement of fasting glucose, insulin, HbA1c and calculation of HOMA-IR
Changes in oxidative stress markers
时间窗: Baseline and week 12
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Paraoxonase Enzyme Activity (PON-1), Total Thiol, Native Thiol, Superoxide Dismutase (SOD), oxidized-LDL, Glutathione peroxidase,Malondialdehyde (MDA), Glutathione (GSH), non-esterified fatty acids (NEFA))
Changes in Inflammatory Parameters
时间窗: Baseline and week 12
Measurement of serum cytokines levels (C-reaktive protein (CRP), IL-10, IL-6, IL-8, IL-1 beta, TNF-alpha
Changes in hepatic steatosis
时间窗: Baseline and week 12
Hepatic steatosis was evaluated according to liver ultrasonography records during the routine controls of all patients.
Changes in liver function tests
时间窗: Baseline and week 12
Measurement of Alanine transaminase (ALT),Aspartate transaminase (AST),Gamma-glutamyltransferase (GGT),Alkaline phosphatase (ALP)
次要结局
- Changes in serum cholesterol levels(Baseline and week 12)
- Changes in some adipokines(Baseline and week 12)
- Changes in triglycerides(Baseline and week 12)
- Changes in waist, hip and neck circumference(baseline, week 2, week 4, week 6, week 8, week 10 and week 12)
- Changes in Body Fat(baseline, week 2, week 4, week 6, week 8, week 10 and week 12)
- Changes in BMI(baseline, week 2, week 4, week 6, week 8, week 10 and week 12)
- Changes in blood pressure(Baseline and week 12)
研究者
GAMZE YURTDAŞ
Research Assistant
Gazi University