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Formula Diet Treatment for NASH Patients. (NASH)

Primary Purpose

Steatohepatitis, Nonalcoholic

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Formula diet

About this trial

This is an interventional treatment trial for Steatohepatitis, Nonalcoholic focused on measuring overweight, fatty liver

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Düsseldorf Catholic Hospital Group
Praxis Prof. ErhardtRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lifestyle intervention

Arm Description

Nutrition advices and formula diet

Outcomes

Primary Outcome Measures

degree of steatosis

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

Secondary Outcome Measures

degree of steatosis

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

degree of fibrosis

degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography

fat mass

fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)

Glutamate Pyruvate Transaminase (GPT)

Glutamate Pyruvate Transaminase in units/litre (U/L)

Gamma-glutamyltransferase (GGT)

Gamma-glutamyltransferase in units/litre (U/L)

insulin

insulin in micro units per millilitre (µU/ml)

Full Information

NCT ID

NCT04707651

First Posted

January 11, 2021

Last Updated

July 19, 2022

Sponsor

West German Center of Diabetes and Health

1. Study Identification

Unique Protocol Identification Number

NCT04707651

Brief Title

Formula Diet Treatment for NASH Patients.

Acronym

NASH

Official Title

Formula Diet Treatment for Weight Reduction in NASH Patients.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 18, 2021 (Actual)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

West German Center of Diabetes and Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Steatohepatitis, Nonalcoholic

Keywords

overweight, fatty liver

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Lifestyle intervention including formula diet

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle intervention

Arm Type

Experimental

Arm Description

Nutrition advices and formula diet

Intervention Type

Dietary Supplement

Intervention Name(s)

Formula diet

Intervention Description

Formula diet for 12 weeks

Primary Outcome Measure Information:

Title

degree of steatosis

Description

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

degree of steatosis

Description

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

Time Frame

52 weeks

Title

degree of fibrosis

Description

degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography

Time Frame

12 weeks and 52 weeks

Title

fat mass

Description

fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)

Time Frame

12 weeks and 52 weeks

Title

Glutamate Pyruvate Transaminase (GPT)

Description

Glutamate Pyruvate Transaminase in units/litre (U/L)

Time Frame

12 weeks and 52 weeks

Title

Gamma-glutamyltransferase (GGT)

Description

Gamma-glutamyltransferase in units/litre (U/L)

Time Frame

12 weeks and 52 weeks

Title

insulin

Description

insulin in micro units per millilitre (µU/ml)

Time Frame

12 weeks and 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stephan Martin, MD

Phone

+49(0)211-5660360

Ext

stephan.martin@uni-duesseldorf.de

First Name & Middle Initial & Last Name or Official Title & Degree

Kerstin Kempf, PhD

Phone

+49(0)211-5660360

Ext

kerstin.kempf@wdgz.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan Martin, MD

Organizational Affiliation

West-German Centre of Diabetes and Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Düsseldorf Catholic Hospital Group

City

Düsseldorf

ZIP/Postal Code

40591

Country

Germany

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martin

First Name & Middle Initial & Last Name & Degree

Kempf

First Name & Middle Initial & Last Name & Degree

Stephan Martin, MD

Facility Name

Praxis Prof. Erhardt

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andreas Erhardt, MD

First Name & Middle Initial & Last Name & Degree

Christian Laumann

First Name & Middle Initial & Last Name & Degree

Andreas Erhardt, MD

First Name & Middle Initial & Last Name & Degree

Christian Laumann, MD

12. IPD Sharing Statement

Learn more about this trial

Formula Diet Treatment for NASH Patients.

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