NCT02491229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 14, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

February 3, 2015

Last Update Submit

January 13, 2016

Conditions

Non-alcoholic Fatty Liver Disease (NAFLD)Obesity

Keywords

non-alcoholic fatty liver disease (NAFLD)ObesityHepafast

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • 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.

  • +10 more secondary outcomes

Study Arms (2)

"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).

Other: Hepafast

Control

OTHER

This group follows the instruction of the LOGI diet for the entire 12 weeks

Other: LOGI diet

Interventions

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

"Hepafast"
LOGI dietOTHER

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

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI between 30-40 kg/m2
  • suspected or diagnosed non-alcoholic fatty liver disease (NAFLD)

You may not qualify if:

  • other liver diseases
  • kidney failure
  • pregnancy, lactation
  • diabetes mellitus which is treated with insulin
  • alcohol abuse
  • several drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, 70599, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesity

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stephan C. Bischoff

    University of Hohenheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Stephan C. Bischoff, MD, Professor

Study Record Dates

First Submitted

February 3, 2015

First Posted

July 7, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

December 1, 2015

Last Updated

January 14, 2016

Record last verified: 2016-01

Locations

DE(1)