The effects of plant sterol and plant stanol ester enriched foods on liver inflammation in subjects at risk to develop NASH - NASH@risk

niversiteit Maastricht0 个研究点目标入组 90 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•1. Be able to give written informed consent
•2. Metabolic syndrome according to the NCEP ATP III definition (Grundy 2005)
•3. Aged between 18 and 75 years
•4. Willingness to consume 20 grams of margarine provided by us on a daily basis
•for a period of 6 months

•1. Are less than 18 years of age or over 75 years of age
•2. Females who are pregnant, breast feeding or who may wish to become pregnant
•during the study
•3. 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
•4. Severe medical conditions that might interfere with the study such as
•epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel
•disease and rheumatoid arthritis
•5. Use of diuretics or insulin therapy
•6. History of illicit drug use
•7. Consume more than the recommended alcohol guidelines i.e. >21 alcohol
•units/week for males and >14 units/week for females
•8. 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)
•9. Use of an investigational product in another biomedical study within the
•previous month

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