Non-Alcoholic Fatty Liver Disease Clinical Trial
Official title:
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
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, which needs to be validated in humans in a translational
approach. In the current proposed pilot study, the effect of consuming plant sterol or plant
stanol esters on biopsy proven liver inflammation will be investigated in NAFLD patients.
The objective is to assess the effect of consuming plant sterol or plant stanol esters (3
grams/day) for 12 months on biopsy proven liver inflammation in NAFLD patients.
This study is a randomized, placebo-controlled, double blinded pilot study with a run-period
of 2 weeks, an intervention period of 12 months and a wash-out period of 1 month.
The study population consists of 15 patients with biopsy-proven liver inflammation, aged
18-75 years.
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
12 months. The primary outcome parameter in this study is biopsy proven liver inflammation.
The objective is to assess the effect of consuming plant sterol or plant stanol esters (3
grams/day) for 12 months on biopsy proven liver inflammation in NAFLD patients.
This study is a randomized, placebo-controlled, double blinded pilot study with a run-period
of 2 weeks, an intervention period of 12 months and a wash-out period of 1 month.
The study population consists of 15 patients with biopsy-proven liver inflammation, aged
18-75 years.
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
12 months. The primary outcome parameter in this study is biopsy proven liver inflammation.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05480696 -
Soluble Fibre Supplementation in NAFLD
|
Phase 1 | |
| Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
| Completed |
NCT04671186 -
Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan
|
N/A | |
| Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
| Recruiting |
NCT05462353 -
Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH
|
Phase 2 | |
| Completed |
NCT05006885 -
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
|
Phase 1 | |
| Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
| Recruiting |
NCT04365855 -
The Olmsted NAFLD Epidemiology Study (TONES)
|
N/A | |
| Recruiting |
NCT05618626 -
Prevention of NAFLD and CVD Through Lifestyle Intervention
|
N/A | |
| Completed |
NCT03256526 -
6-week Safety and PD Study in Adults With NAFLD
|
Phase 2 | |
| Enrolling by invitation |
NCT06152991 -
Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy
|
Phase 3 | |
| Completed |
NCT03681457 -
Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects
|
Phase 1 | |
| Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
| Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
| Completed |
NCT03060694 -
Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
|
||
| Completed |
NCT02526732 -
Hepatic Inflammation and Physical Performance in Patients With NASH
|
N/A | |
| Recruiting |
NCT01988441 -
The Influence of Autophagy on Fatty Liver
|
||
| Recruiting |
NCT01680003 -
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
| Completed |
NCT01712711 -
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
|
Phase 2 | |
| Recruiting |
NCT00941642 -
Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease
|
Phase 4 |