Influence of a Different Percentage of Nutrients on the Effects of a Low-calorie Mediterranean Diet Associated With Physical Exercise on the Parameters of Steatosis, Intestinal Function and Metabolic Risk in Patients With Obesity and NAFLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The effect of intervention on CAP value
研究概览
简要总结
The study in question is an interventional study with nutritional intervention.
The aim of the study is to evaluate whether the adoption of two different models of Mediterranean Diet, based on the different percentage of carbohydrates and lipids, associated with a program of moderate intensity aerobic physical exercise, in patients with obesity and NAFLD can exercise, after only 3 months, effects on:
- specific aspects associated with NAFLD, such as the degree of hepatic steatosis and fibrosis;
- circulating levels of molecules correlated with the degree of generalized and hepatic inflammation and the blood concentrations of metabolic and cardiovascular risk factors associated with abdominal obesity;
- intestinal barrier;
- body composition;
- intestinal microbiota;
- symptoms of IBS (irritable bowel syndrome) in patients with NAFLD.
详细描述
BACKGROUND Chronic liver diseases are among the main causes of morbidity and mortality. Increasing liver disease mortality has been associated with increasing prevalence of NAFLD. The term "fatty liver disease" is the hallmark of NAFLD and refers to a fat deposit in liver cells greater than 5% that is not related to alcohol intake, viral infections, or drug use. Hepatic steatosis is an independent risk factor for all liver alterations that characterize NAFLD and, in particular, inflammation and fibrosis.
The percentage of NAFLD tends to increase with increasing BMI, Age, Presence of metabolic diseases such as dyslipidemia, Type 2 diabetes.
The following are involved in the onset and progression of NAFLD:
- insulin resistance
- generalized inflammation;
- intestine-liver pathways
- intestinal microbiota. In the absence of officially approved pharmacological therapies for the treatment of NAFLD, the guidelines recommend lifestyle-based interventions, both in quantitative and qualitative terms in diet and increased physical exercise. Diet can improve NAFLD by reducing the amount of liver fat and insulin resistance, while exercise promotes weight loss and improves liver function.
Limiting calorie intake in diets, reducing alcohol consumption, and reducing consumption of highly processed foods have proven to be the most important factor in the management of NAFLD.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 30 Kg/m2 or an abdominal circumference (waist) > 94 cm in men and > 80 cm in women (IDF criteria for the definition of abdominal obesity) with or without the characteristics that characterize metabolic syndrome
- •Age range between 18 and 60 years, both sexes
- •Diagnosis of hepatic steatosis, formulated on the basis of recognized criteria (fibroscan [CAP (controlled attenuation parameter) > 238 dB/m], FLI).
排除标准
- •Normal weight and underweight subjects
- •Presence of any pathology that could influence the presence of steatosis apart from the pathologies that represent inclusion criteria
- •Treatment with any device, pharmacological or otherwise, which can influence hepatic metabolism and, therefore, the presence of steatosis
- •Pregnancy or breastfeeding
- •Subjects with osteo-articular pathologies that may prevent regular physical exercise
研究组 & 干预措施
Intervention arm 1
The 1st arm involves a low-calorie diet, which respects the criteria of the Mediterranean diet, with the following macronutrient percentage: carbohydrates 50% of total calories, lipids 30% of total calories, proteins 20% of total calories.
The dietary intervention will be combined with moderate intensity exercise (outdoor walking).
干预措施: Mediterranean diet and moderate intensity physical exercise (outdoor walking). (Other)
Intervention arm 2
The 2nd arm involves a low-calorie diet, which respects the criteria of the Mediterranean diet, with the following percentage of macronutrients: carbohydrates 30% of total calories, lipids 50% of total calories, proteins 20% of total calories.
The dietary intervention will be combined with moderate intensity exercise (outdoor walking).
干预措施: Mediterranean diet and moderate intensity physical exercise (outdoor walking). (Other)
结局指标
主要结局
The effect of intervention on CAP value
时间窗: at Baseline and after 90 days
To evaluate whether the adoption of one of the two different models of the Mediterranean diet, based on different percentages of carbohydrates and lipids, combined with a moderate-intensity aerobic exercise programme, in patients with obesity and NAFLD can exert favourable effects on the CAP value and the degree of liver fibrosis assessed by Fibroscan after only 3 months. Values considered normal are less than 5.1 kPa (kPascal)
The effect of intervention on FLI value
时间窗: at Baseline and after 90 days
To evaluate whether the adoption of one of the two different models of the Mediterranean diet, based on different percentages of carbohydrates and lipids, combined with a moderate-intensity aerobic exercise programme, in patients with obesity and NAFLD can exert favourable effects on the FLI value (fatty liver index), based on anthropometric parameters (BMI, abdominal circumference) and blood chemistry (triglycerides and γGT). Values considered normal are less than 30.
The effect of intervention on routine blood chemistry parameters, relating to NAFLD and fibrosis, nutritional status, inflammatory status and metabolic and cardiovascular risk
时间窗: at Baseline and after 90 days
To evaluate whether the adoption of one of two different Mediterranean diet models, based on different percentages of carbohydrates and lipids, combined with a moderate intensity aerobic exercise program, in patients with obesity and NAFLD can exert favorable effects on routine blood chemistry tests parameters, relating to NAFLD, fibrosis, nutritional and inflammatory status, metabolic and cardiovascular risk. The following will be considered: blood sugar, insulin, glycated hemoglobin, triglycerides, total cholesterol, HDL and LDL, transaminases, γGT, creatinine, uric acid, blood count, ferritin, vitamin D, calcemia, IGF-I, TSH, FT3, FT4, proBNP and HOMA INDEX, adipokines (leptin, adiponcetin, RBP-4, resistin, visfatin, chemerin), hepatic growth factors (HGF, Fetuin-A, FGF21, FGF19, PAI-1) and proinflammatory cytokines (C-Reactive Protein, IL-6, IL-8, TNF-α) and anti-inflammatory (IL-4).
The effect of the intervention on the integrity of the intestinal barrier
时间窗: at Baseline and after 90 days
To evaluate whether the adoption of one of two different Mediterranean diet models, based on different percentages of carbohydrates and lipids, combined with a moderate intensity aerobic exercise program, in patients with obesity and NAFLD can exert favorable effects on the function and integrity of the intestinal barrier assessed by measuring Zonulin, I-FABP, DAO.
次要结局
- The effect of the intervention on the Gastrointestinal Symptoms(at Baseline and after 90 days)
- The effect of the intervention on the Body Composition(at Baseline and after 90 days)
研究者
Prof. Giovanni De Pergola, MD
Prof., MD
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis