Formula Diet Treatment for NASH Patients. | NCT04707651

Studies
Formula Diet Treatment for NASH Patients.

NCT04707651

Sponsor

West German Center of Diabetes and Health

Status

Active, not recruiting

Last Update Posted

Jun 4, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Steatohepatitis, Nonalcoholic

Interventions

Formula diet

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2021Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 11, 2021

First Submission Date that Met QC Criteria

Jan 11, 2021

First Posted Date

Jan 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2026

Last Update Posted Date

Jun 4, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stephan Martin, Principal investigator, West German Center of Diabetes and HealthPrincipal Investigator

Lead Sponsor

West German Center of Diabetes and HealthOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lifestyle intervention	Experimental	Nutrition advices and formula diet	Dietary Supplement: Formula diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Formula diet	Dietary Supplement	Formula diet for 12 weeks	Lifestyle intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
degree of steatosis	degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation	12 weeks

Secondary Outcomes

Measure	Description	Time Frame
degree of steatosis	degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation	52 weeks
degree of fibrosis	degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI>25 kg/qm

Exclusion Criteria:

history of drug or alcohol abuse
acute or chronic diseases (except type 2 diabetes)
pregnancy or breast feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stephan Martin, MD	West-German Centre of Diabetes and Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Düsseldorf Catholic Hospital Group		Düsseldorf		40591	Germany
Praxis Prof. Erhardt

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D050177	Overweight
D005234	Fatty Liver

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005526	Food, Formulated

Ancestor Terms

ID	Term
D019648	Foods, Specialized
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided