Formula Diet Treatment for NASH Patients.

Steatohepatitis, Nonalcoholic Clinical Trial

— NASH  

Official title:

Formula Diet Treatment for Weight Reduction in NASH Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04707651
• Other study ID #: NASH
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: January 2024
• Source: West German Center of Diabetes and Health
• Contact: Stephan Martin, MD
• Phone: +49(0)211-5660360
• Email: stephan.martin[@]uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Steatohepatitis, Nonalcoholic

Intervention

Dietary Supplement:
• Formula diet
Formula diet for 12 weeks

Locations

Country	Name	City	State
Germany	Düsseldorf Catholic Hospital Group	Düsseldorf
Germany	Praxis Prof. Erhardt	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
West German Center of Diabetes and Health

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of steatosis	degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation	12 weeks
Secondary	degree of steatosis	degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation	52 weeks
Secondary	degree of fibrosis	degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography	12 weeks and 52 weeks
Secondary	fat mass	fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)	12 weeks and 52 weeks
Secondary	Glutamate Pyruvate Transaminase (GPT)	Glutamate Pyruvate Transaminase in units/litre (U/L)	12 weeks and 52 weeks
Secondary	Gamma-glutamyltransferase (GGT)	Gamma-glutamyltransferase in units/litre (U/L)	12 weeks and 52 weeks
Secondary	insulin	insulin in micro units per millilitre (µU/ml)	12 weeks and 52 weeks