The Effects of Plant Sterol and Plant Stanol Ester Enriched Foods on Liver Inflammation in Subjects at Risk to Develop NASH
试验速览
- 阶段
- 不适用
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Liver inflammation
研究概览
简要总结
This study is a randomized, placebo-controlled, double blinded pilot study to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT concentrations, i.e. who are at risk to develop NASH.
详细描述
Rationale: As the prevalence of obesity is reaching epidemic proportions, the prevalence of non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH), increases concomitantly and becomes a major global health hazard. Successful pharmacological interventions to treat or prevent NASH are not available and so far only weight loss has clear benefits, but sustained weight-loss is difficult to achieve on the longer-term. We recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation. Moreover, Javanmardi and co-workers recently observed reduced plasma concentrations of Alanine Transaminase (ALT) and Aspartate Transaminase (AST) after daily plant sterol consumption (1.6 g/d) for 6 weeks in a population of adult NAFLD patients. In the current study, we propose to evaluate the effect of long-term consuming plant sterol or plant stanol esters on ALT concentrations in subjects who are at risk to develop NASH. Furthermore, we want to demonstrate the effect of plant sterol and plant stanol consumption on other parameters reflecting liver health, such as cathepsin-D, liver fat and liver insulin sensitivity.
Objective: To assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 6 months on ALT concentrations in subjects with elevated ALT concentrations, i.e. who are at risk to develop NASH.
Study design: This study is a randomized, placebo-controlled, double blinded pilot study with a run-period of 2 weeks, an intervention period of 6 months and a wash-out period of 1 month.
Study population: 90 subjects with elevated ALT concentrations (>ULN), aged 18-75 years.
Intervention: All subjects will start a run-in period of two weeks during which they consume daily 20 grams of control margarine after which they will be randomly allocated to consume 20 grams control margarine or plant sterol or plant stanol enriched margarine on a daily basis for a period of 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Colour-coded margarin tubs
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be able to give written informed consent
- •Elevated ALT concentrations (>50 U/L for men and >40 U/L for women)
- •Metabolic syndrome according to the NCEP ATP III definition (Grundy 2005)
- •Aged between 18 and 75 years
- •Willingness to consume 20 grams of margarine provided by us on a daily basis for a period of 6 months
排除标准
- •Are less than 18 years of age or over 75 years of age
- •Females who are pregnant, breast feeding or who may wish to become pregnant during the study
- •Have a significant acute or chronic coexisting illness such as cardiovascular disease, chronic kidney disease, gastrointestinal disorder, endocrinological disorder, immunological disorder, cancer or any condition which contraindicates, in the investigator's judgement, entry to the study
- •Severe medical conditions that might interfere with the study such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel disease and rheumatoid arthritis
- •Use of diuretics or insulin therapy
- •History of illicit drug use
- •Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females
- •Not willing to stop the consumption of plant sterol or plant stanol enriched products 1 month before the start of the study (wash-in period)
- •Use of an investigational product in another biomedical study within the previous month
结局指标
主要结局
Liver inflammation
时间窗: 6 months
ALT levels
次要结局
- Glucose metabolism(6 months)
研究者
Jogchem Plat
Professor
Maastricht University Medical Center