NASH - Nonalcoholic Steatohepatitis Clinical Trial
— ADLHOfficial title:
Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health (ADLH)"
NCT number | NCT03897218 |
Other study ID # | 17-105 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 20, 2019 |
Est. completion date | April 30, 2022 |
Verified date | August 2023 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 75 Years |
Eligibility | Inclusion Criteria: - Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (> 280dB) - compliance Exclusion Criteria: - Allergy to oats - Alcohol intake of more than 30 g/d (men) or 20 g/d (women) - Treatment with ursodeoxycholic acid (UDCA), vitamin E or other NASH drugs 3 months prior to randomization - Hepatocellular carcinoma or non-hepatic malignancy within the last 5 years - Evidence of cirrhosis of the liver (Child A, B, C) or a history of decompensation - Liver diseases not related to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinically manifest iron overload (heterozygous HFE is permitted), cholestatic liver disease (PBC/PSC) - Adiposity surgery in the last 5 years - BMI <18.5 kg / m2 - Liver transplantation - Fibroscan> 12 kPa (patients with liver cirrhosis) - Lack of CAP and ultrasound evaluation - Age > 75 years - HIV infection - Heart Failure (New York Heart Association Class III - IV) - Myocardial infarction, unstable coronary artery disease, coronary artery intervention or stroke in the last 6 months - Unstable COPD, chronic inflammatory bowel disease or rheumatoid arthritis - Unstable renal failure (changes in serum creatinine > 50% in the last 3 months) or terminal renal failure requiring dialysis - Uncontrolled hypertension (SBP / DBP> 180/90 despite therapy) - Uncontrolled metabolic conditions (poorly controlled or decompensated diabetes mellitus, HbA1c >7.5%) - Food allergies or intolerances that require strict adherence to a diet, such as lactose intolerance or celiac disease. - Pregnancy or breastfeeding women (anamnesis) - Treatment with drugs or substances that can induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or alleviate NASH (TNF antagonists) (e.g. metformin) - Use of herbal food supplements - Any participant who has taken antibiotics 6 weeks prior to the study |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna | |
Germany | University Hospital RWTH Aachen | Aachen | |
Sweden | Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Austria, Germany, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Influence of dietary supplement in oat bran on concentration of AST | Determination of AST concentration (U/l) in blood samples | 20 weeks | |
Secondary | Influence of dietary supplement in oat bran on the concentration of gamma-GT | Determination of gamma-GT concentration (U/l) in blood samples | 20 weeks | |
Secondary | Influence of dietary supplement in oat bran on liver steatosis | Sonography - Performing an abdominal ultrasound examination to detect liver steatosis | 20 weeks | |
Secondary | Influence of dietary supplement in oat bran on bile acid metabolism | Determination of bile acid composition in stool samples | 20 weeks | |
Secondary | 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 | |
Secondary | Influence of dietary supplement in oat bran on intestinal permeability marker like citrullin | Determination of intestinal permeability marker like citrullin (µmol/l) | 20 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Influence of dietary supplement in oat bran on blood pressure | Measurement of blood pressure (mmHg) | 20 weeks | |
Secondary | 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 | |
Secondary | 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 |
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