NL-OMON55602招募中不适用
The effects of plant sterol and plant stanol ester enriched foods on biopsy proven liver inflammation in NAFLD patients - a proof-of-concept pilot study - - Plant sterols, plant stanols and liver inflammation
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- be able to give written informed consent
- •- diagnosed with liver inflammation by a liver biopsy <12 months prior to start
- •of the study. All patients with biopsies older than 2 months must have a stable
- •weight and biochemical liver test results. A certified, experienced pathologist
- •will assess the presence of liver inflammation.
- •- no presence of cirrhosis as diagnosed by the liver biopsy or by the FibroScan
- •- age between 18 and 75 years
- •- Body Mass Index (BMI) <40 kg/m2
- •- willingness to consume 20 grams of margarine on a daily basis for a period of
排除标准
- •- age below 18 years or over 75 years
- •- females who are pregnant, breast feeding or who may wish to become pregnant
- •during the study
- •- 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 investigators judgement, entry to the study
- •- a 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
- •- use of anticoagulants
- •- history of illicit drug use
- •- consumption of more than the recommended alcohol guidelines i.e. >21 alcohol
- •units/week for males and >14 units/week for females
- •- 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
- •- contraindications for MRI
研究者
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