NCT02491229|Completed
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
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Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
February 3, 2015
Actual (reported)May 2015
Actual (reported)July 7, 2015
Actual (reported)December 2015
Actual (reported)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.
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.
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
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
For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).
University of Hohenheim
Stuttgart, 70599, Germany
Stephan C. Bischoff
University of Hohenheim
40 participants (actual enrollment reported by the registry).
First Submitted
February 3, 2015
First Posted
July 7, 2015
Study Start
January 2015
Date type not reportedThis date has not been verified as actual or estimated.
Metabolic Flexibility, Gut Microbiota, Healthy Diet and Exercise in NAFLD on Genetics Base
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
January 14, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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