NCT04707651

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

July 11, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

January 11, 2021

Last Update Submit

July 10, 2024

Conditions

Steatohepatitis, Nonalcoholic

Keywords

overweightfatty liver

Outcome Measures

Primary Outcomes (1)

  • degree of steatosis

    degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation

    12 weeks

Secondary Outcomes (6)

  • degree of steatosis

    52 weeks

  • degree of fibrosis

    12 weeks and 52 weeks

  • fat mass

    12 weeks and 52 weeks

  • Glutamate Pyruvate Transaminase (GPT)

    12 weeks and 52 weeks

  • Gamma-glutamyltransferase (GGT)

    12 weeks and 52 weeks

  • +1 more secondary outcomes

Study Arms (1)

Lifestyle intervention

EXPERIMENTAL

Nutrition advices and formula diet

Dietary Supplement: Formula diet

Interventions

Formula dietDIETARY_SUPPLEMENT

Formula diet for 12 weeks

Lifestyle intervention

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>25 kg/qm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Düsseldorf Catholic Hospital Group

Düsseldorf, 40591, Germany

Location

Praxis Prof. Erhardt

Wuppertal, 42283, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseOverweightFatty Liver

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Foods, SpecializedFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Stephan Martin, MD

    West-German Centre of Diabetes and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Lifestyle intervention including formula diet
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 11, 2021

First Posted

January 13, 2021

Study Start

January 18, 2021

Primary Completion

December 31, 2024

Study Completion

March 31, 2025

Last Updated

July 11, 2024

Record last verified: 2024-07

Locations

DE(2)