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

NCT03897218 | Completed

• 1 other identifier: 17-105
• Study Type: interventional
• Target: 84
• Locations: 3 countries
• Sites: 3

Brief Summary

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.

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Liver health; Diet; Microbiom

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Influence of dietary supplement in oat bran on concentration of AST

  20 weeks

• Influence of dietary supplement in oat bran on the concentration of gamma-GT

  20 weeks

• Influence of dietary supplement in oat bran on liver steatosis

  20 weeks

• Influence of dietary supplement in oat bran on bile acid metabolism

  20 weeks

• Influence of dietary supplement in oat bran on the composition of the intestinal microbiome

  20 weeks

Study Arms (3)

Group 1

PLACEBO COMPARATOR

Patients consuming placebo (millet flakes) each day

Dietary Supplement: millet flakes

Group 2

EXPERIMENTAL

Patients consuming oatmeal flakes with a low dosage of prebiotic food supplements

Dietary Supplement: oatmeal flakes with prebiotic food supplements

Group 3

EXPERIMENTAL

Patients consuming oatmeal flakes with a high dosage of prebiotic food supplements

Dietary Supplement: oatmeal flakes with prebiotic food supplements

Interventions

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.

Group 2; Group 3

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.

Group 1

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (\> 280dB)
• compliance

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (3)

Medical University of Vienna

Vienna, Austria

Location

University Hospital RWTH Aachen

Aachen, Germany

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 41438070 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Christian Trautwein, Prof. Dr.

  Uniklinik RWTH Aachen, Med. Klinik III

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: April 1, 2019
• Study Start: May 20, 2019
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: August 16, 2023

Record last verified: 2023-08

Locations

AU (1); SE (1); DE (1)