Back to results"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
Primary Purpose
Non-alcoholic Fatty Liver Disease (NAFLD), Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hepafast
LOGI diet
Sponsored by
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease (NAFLD) focused on measuring non-alcoholic fatty liver disease (NAFLD), Obesity, Hepafast
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
Sites / Locations
- University of Hohenheim
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
"Hepafast"
Control
Arm 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).
This group follows the instruction of the LOGI diet for the entire 12 weeks
Outcomes
Primary Outcome Measures
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Secondary Outcome Measures
change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
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
change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Full Information
NCT ID
NCT02491229
First Posted
February 3, 2015
Last Updated
January 13, 2016
Sponsor
University of Hohenheim
Collaborators
Bodymed AG
1. Study Identification
Unique Protocol Identification Number
NCT02491229
Brief Title
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
Official Title
Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Hohenheim
Collaborators
Bodymed AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease (NAFLD), Obesity
Keywords
non-alcoholic fatty liver disease (NAFLD), Obesity, Hepafast
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
"Hepafast"
Arm Type
Other
Arm 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).
Arm Title
Control
Arm Type
Other
Arm Description
This group follows the instruction of the LOGI diet for the entire 12 weeks
Intervention Type
Other
Intervention Name(s)
Hepafast
Intervention Description
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
Intervention Name(s)
LOGI diet
Intervention Description
For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).
Primary Outcome Measure Information:
Title
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Secondary Outcome Measure Information:
Title
change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
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
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Title
change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time Frame
Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C. Bischoff
Organizational Affiliation
University of Hohenheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Hohenheim
City
Stuttgart
ZIP/Postal Code
70599
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
We'll reach out to this number within 24 hrs