"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491229
• Other study ID #: ZKES HEPA V2.0
• Status: Completed
• Phase: N/A
• First received: February 3, 2015
• Last updated: January 13, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease (NAFLD)
• Obesity

Intervention

Other:
• Hepafast
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
• LOGI diet
For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).

Locations

Country	Name	City	State
Germany	University of Hohenheim	Stuttgart

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	Bodymed AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No