Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Studies in recent years have demonstrated that the commensal intestinal flora (microbiome) plays a key role in the development of nonalcoholic steatohepatitis (NASH). An unfavourable microbiom can trigger disease development and progression. On the other hand, recent data show that modulation of the microbiom by a diet can prevent the developement of a NASH. Mechanisms of interaction between nutrition, microbiome, intestine and liver are largely unknown. In this research project, the effect of a fibre-rich oat bran on NASH will therefore be investigated. A better understanding of the interaction between diet, microbiome, intestine and liver could form the basis for new preventive therapies of NASH.
In recent years, the results of animal experiments and some human intervention studies indicate that the commensal intestinal flora (microbiome) plays a key role in the development of nonalcoholic steatohepatitis (NASH). An unfavourable composition of the microbiome can trigger disease development and progression. On the other hand, recent data show that modulation of the microbiome through diet, such as a high-fibre diet, can prevent the developement of a NASH. It has been shown that the uptake of fibre-rich oats reduces LDL and total cholesterol without altering the HDL cholesterol level. Indeed, the results of several human intervention studies suggest that a regular intake of oat flakes with prebiotic food supplements is sufficient to lower LDL and total cholesterol levels. In a small clinical trial it was also shown that an intake of oat bran with prebiotic food supplements in two servings per day was associated with a significant reduction in ALT and AST activity in the serum of overweight individuals with signs of altered liver function. In addition, the use of oat bran to influence postprandial glucose and insulin response and satiety was discussed.
However, the mechanisms underlying the positive effects of treatments with pro-, pre- or synbiotics are not yet fully understood and generally accepted therapeutic strategies are still lacking. The exact influence of a fibre-rich diet on intestinal microbiom and bile acid composition is not yet known. In the research project described, the effect of oat bran with prebiotic food supplements on NASH will be investigated and mechanisms of interaction between diet, microbiome, bile acids and liver will be uncovered. A better understanding of this interaction could form the basis for new preventive therapies of NASH.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Patients consuming placebo (millet flakes) each day |
|
| Group 2 | Experimental | Patients consuming oatmeal flakes with a low dosage of prebiotic food supplements |
|
| Group 3 | Experimental | Patients consuming oatmeal flakes with a high dosage of prebiotic food supplements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oatmeal flakes with prebiotic food supplements | Dietary Supplement | The study participants should consume the prescribed amount of the study product every day. The intake should be divided into 1-2 meals. It is not necessary to limit or change normal eating habits. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the influence of a dietary supplement in oat bran on the course of disease in the early stages of NASH by CAP (Controlled Attenuation Parameter) measurement to determine liver steatosis. | CAP measurement (dB/m) | 20 weeks |
| Evaluation of the influence of a dietary supplement in oat bran on the course of disease in the early stages of NASH by determination ALT-concentration in blood samples. | Determination of ALT concentration (U/l) in blood samples | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Influence of dietary supplement in oat bran on concentration of AST | Determination of AST concentration (U/l) in blood samples | 20 weeks |
| Influence of dietary supplement in oat bran on the concentration of gamma-GT |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christian Trautwein, Prof. Dr. | Uniklinik RWTH Aachen, Med. Klinik III | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | Austria | ||||
| University Hospital RWTH Aachen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41438070 | Derived | Brandt A, Yergaliyev T, Halibasic E, Cyba A, Jaeger JW, Gong R, Hernandez-Arriaga A, Schneider CV, Sjoland W, Molinaro A, Trauner M, Trautwein C, Camarinha-Silva A, Bergheim I, Schneider KM. Fiber enrichment is not superior to dietary monitoring in MASLD: A dual-center, double-blind, placebo-controlled trial. iScience. 2025 Nov 11;28(12):114019. doi: 10.1016/j.isci.2025.114019. eCollection 2025 Dec 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| millet flakes | Dietary Supplement | The study participants should consume the prescribed amount of the study product every day. The intake should be divided into 1-2 meals. It is not necessary to limit or change normal eating habits. |
|
Determination of gamma-GT concentration (U/l) in blood samples
| 20 weeks |
| Influence of dietary supplement in oat bran on liver steatosis | Sonography - Performing an abdominal ultrasound examination to detect liver steatosis | 20 weeks |
| Influence of dietary supplement in oat bran on bile acid metabolism | Determination of bile acid composition in stool samples | 20 weeks |
| Influence of dietary supplement in oat bran on the composition of the intestinal microbiome | Determination of microbiom in stool samples (bacterial DNA and RNA are isolated from the stool to determine the microbial composition) | 20 weeks |
| Influence of dietary supplement in oat bran on intestinal permeability marker like citrullin | Determination of intestinal permeability marker like citrullin (µmol/l) | 20 weeks |
| Influence of dietary supplement in oat bran on metabolic markers | Determination of concentration of diffenrent, previously not defined metabolic markers in blood samples by untargeted metabolomics analysis | 20 weeks |
| Influence of dietary supplement in oat bran on inflammatory markers of NASH | Determination of concentration of previously not defined inflammatory markers of NASH in blood samples by multiplex assays | 20 weeks |
| Influence of dietary supplement in oat bran on blood pressure | Measurement of blood pressure (mmHg) | 20 weeks |
| Assessment of quality of life | Questionnaires to evaluate quality of life: EQ-5D-5L EQ-5D questionnaires with 5-point Likert scale: "having no problems", "having slight problems", "having moderate problems", "having severe problems" & "being unable to do/having extreme problems" (the answers euquals 1-5 points, with 5 points beeing the worst outcome) | 20 weeks |
| Assessment of the feeling of satiety/gastrointestinal symptoms | Questionnaire "Structured Assessment of Gastrointestinal Symptoms" (SAGIS): 5-point Likert scale from no problem, mild, moderate, severe and very severe problem (0-4 points; 4 points equals "very severe problem" | 20 weeks |
| Aachen |
| Germany |
| Sahlgrenska University Hospital | Gothenburg | Sweden |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided