Clinical trial NCT02491229: "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
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)
Obesity
Keywords: non-alcoholic fatty liver disease (NAFLD)
Obesity
Hepafast
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: Bodymed AG
First posted: 2015-07-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Secondary outcomes:
measure: change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: 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
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in body weight at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in blood pressure (systolic and diastolic) at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in GGT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in GOT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in GPT at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in AP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in triglycerides at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in HDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in LDL cholesterol at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in fasting glucose at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in insulin at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in HbA1c at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
measure: change from baseline in hsCRP at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
timeFrame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
Study officials:
affiliation: University of Hohenheim
name: Stephan C. Bischoff
role: PRINCIPAL_INVESTIGATOR
References: