Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"
Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"
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.
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