"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
Not Applicable
Completed
- Conditions
- ObesityNon-alcoholic Fatty Liver Disease (NAFLD)
- Interventions
- Other: HepafastOther: LOGI diet
- Registration Number
- NCT02491229
- Lead Sponsor
- University of Hohenheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description "Hepafast" 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). Control LOGI diet This group follows the instruction of the LOGI diet for the entire 12 weeks
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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 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 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 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. 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 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 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 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 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 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.
Trial Locations
- Locations (1)
University of Hohenheim
🇩🇪Stuttgart, Germany