Hepafast in Non-alcoholic Fatty Liver Disease (NAFLD)

Study Overview
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Brief Summary
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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.

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

Conditions
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Non-alcoholic Fatty Liver Disease (NAFLD), Obesity

Intervention / Treatment
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* Other: Hepafast
* Other: LOGI diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, non-alcoholic fatty liver disease (NAFLD), Hepafast