Steatohepatitis, NonalcoholicNASHNCT04707651
Formula Diet Treatment for NASH Patients.
A study testing Formula diet in people with Steatohepatitis, Nonalcoholic, run by West German Center of Diabetes and Health at 2 sites in Germany.
Trial summary
Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Steatohepatitis, Nonalcoholic
- What is being tested?
- Formula diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesGermany
- Study dates
- 18 Jan 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI>25 kg/qm
Who cannot join
- history of drug or alcohol abuse
- acute or chronic diseases (except type 2 diabetes)
- pregnancy or breast feeding
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Düsseldorf Catholic Hospital Group
Düsseldorf, 40591
Praxis Prof. Erhardt
Wuppertal, 42283
About this study
Official title: Formula Diet Treatment for Weight Reduction in NASH Patients.
Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.
Read the detailed description
Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.
- Conditions
- Steatohepatitis, Nonalcoholic
- Being tested
- Formula diet
- Keywords
- overweight, fatty liver
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Overweight, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Formula dietDietary supplement
Formula diet for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle intervention | Experimental | Nutrition advices and formula diet Receives: Dietary Supplement: Formula diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of steatosis
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
Measured: 12 weeks
Secondary outcomes (6)
degree of steatosis
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
Measured: 52 weeks
degree of fibrosis
degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography
Measured: 12 weeks and 52 weeks
fat mass
fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks and 52 weeks
Glutamate Pyruvate Transaminase (GPT)
Glutamate Pyruvate Transaminase in units/litre (U/L)
Measured: 12 weeks and 52 weeks
Gamma-glutamyltransferase (GGT)
Gamma-glutamyltransferase in units/litre (U/L)
Measured: 12 weeks and 52 weeks
insulin
insulin in micro units per millilitre (µU/ml)
Measured: 12 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start18 Jan 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steatohepatitis, NonalcoholicStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lifestyle intervention including formula diet
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West German Center of Diabetes and Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Martin, West German Center of Diabetes and Health
- Investigators
- Stephan Martin, MD, Principal investigator, West-German Centre of Diabetes and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707651
- Sponsor's protocol ID
- NASH
- Acronym
- NASH
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Formula Diet Treatment for Weight Reduction in NASH Patients.
- ClinicalTrials.gov ID
- NCT04707651
- Acronym / sponsor ID
- NASH / NASH
- Conditions
- Steatohepatitis, Nonalcoholic
- Keywords
- overweight, fatty liver
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West German Center of Diabetes and HealthUniversity, hospital or other
- Study start
- 18 Jan 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Jan 2021 (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.
Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.
Detailed description
Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lifestyle intervention including formula diet
| Arm | Type | Receives |
|---|---|---|
| Lifestyle intervention | Experimental | Dietary Supplement: Formula dietNutrition advices and formula diet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI>25 kg/qm
Key exclusion criteria (3 listed)
- history of drug or alcohol abuse
- acute or chronic diseases (except type 2 diabetes)
- pregnancy or breast feeding
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 |
|---|---|---|
| Formula dietFormula diet for 12 weeks | Dietary supplement | Lifestyle intervention |
Primary outcome
degree of steatosis
Time frame: 12 weeks
degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation
6 secondary outcomes
degree of steatosis
Time frame: 52 weeks
degree of fibrosis
Time frame: 12 weeks and 52 weeks
fat mass
Time frame: 12 weeks and 52 weeks
Glutamate Pyruvate Transaminase (GPT)
Time frame: 12 weeks and 52 weeks
Gamma-glutamyltransferase (GGT)
Time frame: 12 weeks and 52 weeks
insulin
Time frame: 12 weeks and 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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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.
Stephan Martin, MD principal investigator
West-German Centre of Diabetes and Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Formula diet in people with Steatohepatitis, Nonalcoholic, run by West German Center of Diabetes and Health at 2 sites in Germany.
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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
degree of steatosis (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.