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

Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Non-alcoholic Fatty Liver Disease (NAFLD)
• Intervention / Treatment: Other: Hepafast; Other: LOGI diet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Stuttgart, Germany, 70599
    • University of Hohenheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: "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).	Other: 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
Other: Control; This group follows the instruction of the LOGI diet for the entire 12 weeks	Other: LOGI diet; For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in the classification of non-alcoholic fatty liver disease (NAFLD) based on ultrasound at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition	Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.

Collaborators and Investigators

• Sponsor: University of Hohenheim
• Collaborators: Bodymed AG

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 3, 2015
• First Submitted That Met QC Criteria: July 2, 2015
• First Posted (Estimate): July 7, 2015

Study Record Updates

• Last Update Posted (Estimate): January 14, 2016
• Last Update Submitted That Met QC Criteria: January 13, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Obesity; non-alcoholic fatty liver disease (NAFLD); Hepafast
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ZKES HEPA V2.0