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Comprehensive Lifestyle Intervention vs. Soy Protein-based Meal Regimen in Patients with Non-alcoholic Steatohepatitis

Comprehensive Lifestyle Intervention vs. Soy Protein-based Meal Regimen in Patients with Non-alcoholic Steatohepatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00014057
Enrollment
26
Registered
2018-11-12
Start date
2011-05-14
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K75.8

Interventions

Group 1: Lifestyle Intervention (guidance in physical activity and nutrition) Group 2: meal replacement (with a commercially available soy-joghurt-honey preparation)

Sponsors

Universitätsklinikum FreiburgPräventive und Rehabilitative Sportmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: BMI between 30 - 40 kg/m² possible participation in sports program elevation of liver enzymes (ALT, AST or ggT)

Exclusion criteria

Exclusion criteria: - performance capacity < 75W for 2 minutes - absolute or relative contraindications to physical training according to the guidelines of the ACSM (American College of Sports Medicine) - insulin-dependent diabetes mellitus - chronic kidney diseasae - intake of appetite modifying medication - psychiatric disease with continued supervision of a physician - history of malignant disease within the last 5 years

Design outcomes

Primary

MeasureTime frame
Change in hepatic lipid content (measured after 24 weeks with MRI)

Secondary

MeasureTime frame
Change in body composition (after 24 weeks, measured by MRI) Change in fat mass (after 24 weeks, measured by BodPod) Changes in liver enzymes (after 24 weeks, measured by standard laboratory methods) Changes in hepatic lipid composition (after 24 weeks, measured by MRI-spectroscopy) Changes in adipokines (after 24 weeks, measured by ELISA)

Countries

Germany

Contacts

Public ContactPeter Deibert

Universitätsklinikum

peter.deibert@uniklinik-freiburg.de+49 761 270 74540

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026