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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 -

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55602
Enrollment
15
Registered
2018-03-29
Start date
2018-08-07
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leverontsteking fatty liver Liver inflammation

Interventions

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - be able to give written informed consent - diagnosed with liver inflammation by a liver biopsy

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
The primary outcome parameter in this study is biopsy proven liver inflammation.

Secondary

MeasureTime frame
- liver inflammation via plasma markers - liver inflammation via MRS - liver inflammation via volatile organic compounds - liver fat via MRS - liver fibrosis via de FibroScan - insulin sensitivity via a hyperinsulinemic-euglycemic clamp - lipid metabolism - glucose metabolism

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)