"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)

University of Hohenheim

Status: Completed

Conditions: Obesity; Non-alcoholic Fatty Liver Disease (NAFLD)

Treatments: Other: LOGI diet; Other: Hepafast

Study type: Interventional

Funder types: Other

Identifiers

NCT02491229

ZKES HEPA V2.0

Details and patient eligibility

About

The purpose of this study is to investigate whether a weight reduction with "Hepafast" in combination with raw food and vegetables for two weeks followed by a meal substitution with "Hepafast" and a calorie restriction in accordance with the Low Glycemic and Insulinemic Diet (LOGI) for 10 weeks is superior regarding improvement of non-alcoholic Fatty Liver Disease (NAFLD) compared to a conventional weight reduction in accordance with the LOGI diet without use of "Hepafast" for 12 weeks.

Enrollment: 40 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI between 30-40 kg/m2
• suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)

Exclusion criteria

• other liver diseases
• kidney failure
• pregnancy, lactation
• diabetes mellitus which is treated with insulin
• alcohol abuse
• several drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

"Hepafast"

Other group

Description:

This group consumes three portions of "Hepafast" and additionally 200 kcal of vegetables for two weeks. In the following ten weeks, they consume two portions of "Hepafast" and one meal which follows the instructions of the Low Glycemic and Insulinemic Diet (LOGI).

Treatment:

Other: Hepafast

Control

Other group

Description:

This group follows the instruction of the LOGI diet for the entire 12 weeks

Treatment:

Other: LOGI diet