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

NCT ID: NCT02491229

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD); Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

"Hepafast"

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).

Group Type: OTHER

Hepafast

Intervention Type: OTHER

Two weeks of Hepafast three times a day and additionally 200 kcal followed by 10 weeks of Hepafast two times a day and a meal according to LOGI diet

Control

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

Group Type: OTHER

LOGI diet

Intervention Type: OTHER

For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).

Interventions

Hepafast

Two weeks of Hepafast three times a day and additionally 200 kcal followed by 10 weeks of Hepafast two times a day and a meal according to LOGI diet

Intervention Type: OTHER

LOGI diet

For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bodymed AG

UNKNOWN

Sponsor Role: collaborator

University of Hohenheim

OTHER

Sponsor Role: lead

Responsible Party

Stephan C. Bischoff, MD, Professor

Stephan C. Bischoff, MD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephan C. Bischoff

Role: PRINCIPAL_INVESTIGATOR

University of Hohenheim

Locations

University of Hohenheim

Stuttgart, , Germany

Countries

Germany

Other Identifiers

ZKES HEPA V2.0

Identifier Type: -

Identifier Source: org_study_id