NASH - Nonalcoholic SteatohepatitisADLHNCT03897218
Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health"
A study testing oatmeal flakes with prebiotic food supplements and millet flakes in people with NASH - Nonalcoholic Steatohepatitis, run by RWTH Aachen University at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- oatmeal flakes with prebiotic food supplements and millet flakes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 20 May 2019to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (> 280dB)
- compliance
Who cannot join
- 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)
Show all 24Show fewer
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health (ADLH)"
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.
Read the detailed description
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.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- oatmeal flakes with prebiotic food supplements, millet flakes
- Keywords
- Liver health, Diet, Microbiom
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oatmeal flakes with prebiotic food supplementsDietary 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.
millet flakesDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Patients consuming placebo (millet flakes) each day Receives: Dietary Supplement: millet flakes |
| Group 2 | Experimental | Patients consuming oatmeal flakes with a low dosage of prebiotic food supplements Receives: Dietary Supplement: oatmeal flakes with prebiotic food supplements |
| Group 3 | Experimental | Patients consuming oatmeal flakes with a high dosage of prebiotic food supplements Receives: Dietary Supplement: oatmeal flakes with prebiotic food supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 20 weeks
Secondary outcomes (11)
Influence of dietary supplement in oat bran on concentration of AST
Determination of AST concentration (U/l) in blood samples
Measured: 20 weeks
Influence of dietary supplement in oat bran on the concentration of gamma-GT
Determination of gamma-GT concentration (U/l) in blood samples
Measured: 20 weeks
Influence of dietary supplement in oat bran on liver steatosis
Sonography - Performing an abdominal ultrasound examination to detect liver steatosis
Measured: 20 weeks
Influence of dietary supplement in oat bran on bile acid metabolism
Determination of bile acid composition in stool samples
Measured: 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)
Measured: 20 weeks
Influence of dietary supplement in oat bran on intestinal permeability marker like citrullin
Determination of intestinal permeability marker like citrullin (µmol/l)
Measured: 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
Measured: 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
Measured: 20 weeks
Influence of dietary supplement in oat bran on blood pressure
Measurement of blood pressure (mmHg)
Measured: 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)
Measured: 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"
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start20 May 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Trautwein, Prof. Dr., Principal investigator, Uniklinik RWTH Aachen, Med. Klinik III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897218
- Sponsor's protocol ID
- 17-105
- Acronym
- ADLH
- Status last verified
- Aug 2023
- First submitted
- 14 Mar 2019
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41438070
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Modulation of Intestinal Microbiota as Trigger of Liver Health: Role of Bile Acids - "A Diet for Liver Health (ADLH)"
- ClinicalTrials.gov ID
- NCT03897218
- Acronym / sponsor ID
- ADLH / 17-105
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Keywords
- Liver health, Diet, Microbiom
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Dietary Supplement: millet flakesPatients consuming placebo (millet flakes) each day |
| Group 2 | Experimental | Dietary Supplement: oatmeal flakes with prebiotic food supplementsPatients consuming oatmeal flakes with a low dosage of prebiotic food supplements |
| Group 3 | Experimental | Dietary Supplement: oatmeal flakes with prebiotic food supplementsPatients consuming oatmeal flakes with a high dosage of prebiotic food supplements |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Fatty liver disease diagnosed by sonography (steatosis hepatis grade II and III) and CAP measurement (> 280dB)
- compliance
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oatmeal flakes with prebiotic food supplementsThe 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. | Dietary supplement | Group 2, Group 3 |
| millet flakesThe 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. | Dietary supplement | Group 1 |
Primary outcome
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.
Time frame: 20 weeks
CAP measurement (dB/m)
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.
Time frame: 20 weeks
Determination of ALT concentration (U/l) in blood samples
11 secondary outcomes
Influence of dietary supplement in oat bran on concentration of AST
Time frame: 20 weeks
Influence of dietary supplement in oat bran on the concentration of gamma-GT
Time frame: 20 weeks
Influence of dietary supplement in oat bran on liver steatosis
Time frame: 20 weeks
Influence of dietary supplement in oat bran on bile acid metabolism
Time frame: 20 weeks
Influence of dietary supplement in oat bran on the composition of the intestinal microbiome
Time frame: 20 weeks
Influence of dietary supplement in oat bran on intestinal permeability marker like citrullin
Time frame: 20 weeks
Influence of dietary supplement in oat bran on metabolic markers
Time frame: 20 weeks
Influence of dietary supplement in oat bran on inflammatory markers of NASH
Time frame: 20 weeks
Influence of dietary supplement in oat bran on blood pressure
Time frame: 20 weeks
Assessment of quality of life
Time frame: 20 weeks
Assessment of the feeling of satiety/gastrointestinal symptoms
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 41438070Brandt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Trautwein, Prof. Dr. principal investigator
Uniklinik RWTH Aachen, Med. Klinik III
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oatmeal flakes with prebiotic food supplements and millet flakes in people with NASH - Nonalcoholic Steatohepatitis, run by RWTH Aachen University at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03897218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.