Non-alcoholic Fatty Liver Disease (NAFLD)NCT02491229
"Hepafast" in Non-alcoholic Fatty Liver Disease (NAFLD)
A study testing Hepafast and LOGI diet in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Obesity, run by University of Hohenheim at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease (NAFLD), Obesity
- What is being tested?
- Hepafast and LOGI diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 30-40 kg/m2
- suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)
Who cannot join
- other liver diseases
- kidney failure
- pregnancy, lactation
- diabetes mellitus which is treated with insulin
- alcohol abuse
- several drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
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.
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), Obesity
- Being tested
- Hepafast, LOGI diet
- Keywords
- non-alcoholic fatty liver disease (NAFLD), Obesity, Hepafast
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HepafastOther
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 dietOther
For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).
| Study group | Role | What they receive |
|---|---|---|
| "Hepafast" | Other | 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). Receives: Other: Hepafast |
| Control | Other | This group follows the instruction of the LOGI diet for the entire 12 weeks Receives: Other: LOGI diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Measured: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Secondary outcomes (15)
change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver Disease (NAFLD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Bodymed AG
- Responsible party
- Principal investigator, Stephan C. Bischoff, MD, Professor, University of Hohenheim
- Investigators
- Stephan C. Bischoff, Principal investigator, University of Hohenheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491229
- Sponsor's protocol ID
- ZKES HEPA V2.0
- Status last verified
- Jan 2016
- First submitted
- 3 Feb 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Investigating the Effects of "Hepafast" on Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02491229
- Acronym / sponsor ID
- ZKES HEPA V2.0
- Conditions
- Non-alcoholic Fatty Liver Disease (NAFLD), Obesity
- Keywords
- non-alcoholic fatty liver disease (NAFLD), Obesity, Hepafast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Bodymed AG
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 7 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Hepafast" | Other | Other: HepafastThis 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). |
| Control | Other | Other: LOGI dietThis group follows the instruction of the LOGI diet for the entire 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI between 30-40 kg/m2
- suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)
Key exclusion criteria (6 listed)
- other liver diseases
- kidney failure
- pregnancy, lactation
- diabetes mellitus which is treated with insulin
- alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HepafastTwo 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 | Other | "Hepafast" |
| LOGI dietFor twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI). | Other | Control |
Primary outcome
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
15 secondary outcomes
change from baseline in fatty liver index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan C. Bischoff principal investigator
University of Hohenheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepafast and LOGI diet in people with Non-alcoholic Fatty Liver Disease (NAFLD) and Obesity, run by University of Hohenheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in hepatorenal index at two weeks, six weeks and twelve weeks after starting a defined way of nutrition (time frame: Participants will be followed for the time of twelve weeks. Examinations take place at two weeks, six weeks and twelve weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2016.