Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Hematic Levels of Hepatic Enzymes GGT
研究概览
简要总结
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel groups.
The study participants are healthy volunteers, since they do not have nor had any liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for at least one of the liver parameters -aspartate aminotransferase AST, alanine aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic abnormalities of steatosic liver) tests altered as compared to normal ranges.
Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and at the end of treatment - 3 months).
详细描述
A correct hepatic function is highly relevant from the epidemiological point of view. In Italy, Non Alcoholic Fatty Liver Disease - NAFLD - has a prevalence of 20-25% in the adult population, with peaks of 50-70% within obese and type-2 diabetes populations: it is the most frequent cause of hematic changes in cytonecrosis enzymes, and can explain about 90% of asymptomatic high levels of transaminases. NAFLD natural history is associated with an increase of cerebro and cardiovascular risk, in both healthy subjects and diabetic patients.
Its prevention and treatment are of great interest, in particular dietary and nutraceutical interventions are the object of innovative research. It is also known that about 65% of subjects with hepatic dysfunction consume plant extracts, like silymarin from Cardo marianum. A recent trial showed an improvement of the hepatic function in subjects with NAFLD treated with silybin, combined with phosphatidylcholine and vitamin E. These findings provide valuable information on new therapeutic strategies, but warrant further investigation. For no natural substance a health claim related to liver function was in fact approved by the European Food Safety Authority (EFSA). The only exception is constituted by the food sources of choline, for which the maintenance of normal hepatic function has been claimed.
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Treatment: subjects will be randomized to receive the nutraceutical formulation or placebo for three months, in the amount of two capsules (about 800 mg each) a day, at one time.
All subjects, after signing a written informed consent to participation in the study, will receive appropriate recomendations about diet and physical exercise.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects with non alcoholic fatty liver disease (NAFLD)
- •presenting ultrasonographic abnormalities of steatosic liver (hyperechogenic parenchyma)
- •with plasma levels greater than normal (ranges of each recruiting center) for at least one of the following parameters (aspartate aminotransferase AST, alanine aminotransferase ALT, γ -glutamyltranspeptidase γ-GT).
排除标准
- •history of alcohol abuse
- •use of drugs associated with the development of hepatic steatosis
- •malnutrition
- •alcoholic chronic liver disease
- •chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson's disease, deficits of alpha-1 antitrypsin, celiac disease)
- •severe renal, cardiac or respiratory insufficiency
- •malignant tumors
- •intolerance to any component of the active ingredients of the formulation
- •women who are pregnant or have planned the pregnancy within three months and women who are breast-feeding.
结局指标
主要结局
Hematic Levels of Hepatic Enzymes GGT
时间窗: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: gamma-glutamyl transpeptidase (GGT)
Hematic Levels of Hepatic Enzymes AST
时间窗: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: aspartate aminotransferase (AST)
Hematic Levels of Hepatic Enzymes ALT
时间窗: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: alanine aminotransferase (ALT)
次要结局
- Plasma Levels of Hepatic Enzymes(before and at the end of treatment (three months))
- Levels of Circulating Inflammation Marker(before and at the end of treatment (three months))
- Measures of the Haemostatic Function(before and at the end of treatment (three months))
研究者
Giovanni de Gaetano
Head, Department Epidemiology and Prevention
Neuromed IRCCS