Hepafast in Non-alcoholic Fatty Liver Disease (NAFLD)

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02491229

Enrollment

Registered

2015-07-07

Start date

2015-01-31

Completion date

2015-12-31

Last updated

2016-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD), Obesity

Keywords

non-alcoholic fatty liver disease (NAFLD), Obesity, Hepafast

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.

Interventions

OTHERHepafast

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

OTHERLOGI diet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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 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 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.
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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026