Clinical trial NCT02366052: Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study
Official title: Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Fatty Liver, Nonalcoholic
Keywords: Histologically confirmed NASH
Hepatocyte Injury determined by M30 antigen
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: University of Jena
First posted: 2015-02-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the study is to determine if an oral supplementation of the LCS has a beneficial effect by itself or even enhances the beneficial effects of a moderate life-style intervention on the progression of NAFLD in humans.


Eligibility criteria: Inclusion Criteria:

- Elevated M30 antigen levels (cutoff: \>200 - 800 U/L) at screening AND hepatic steatosis on ultrasound

OR histologically confirmed NASH

- Age 18 to 75 years

Exclusion Criteria:

* Alcohol intake of more than 30 g/d (men) or 20 g/d (women)
* Treatment with ursodeoxycholic acid (UDCA), Vitamin E or other investigational NASH drugs 3 months prior to randomization
* Treatment with medications or substances that may induce secondary NASH (e.g., tamoxifen, corticosteroids, amiodarone, methotrexate) or ameliorate NASH (TNF-antagonists)
* Treatment with phenprocoumon or warfarin
* Hepatocellular carcinoma or non-hepatic malignancy
* Decompensated cirrhosis (Child B,C) or a history of decompensation
* Liver disease unrelated to NASH, including chronic viral hepatitis B/D or C, autoimmune hepatitis, Wilson's disease or clinical manifest iron overload
* Bariatric surgery within the last 5 years
* BMI \<18,5 kg/m2 or BMI \>45 kg/m2
* Liver transplantation
* Heart failure (New York Heart Association Class II - IV)
* Myocardial infarction, instable coronary artery disease , coronary artery intervention or stroke in the previous 6 months
* Instable chronic obstructive pulmonary disease, chronic inflammatory bowel disease or rheumatoid arthritis.
* Instable renal insufficiency (changes in serum creatinin \> 50% in the last 3 month) or terminal renal insufficiency requiring dialysis
* Uncontrolled hypertension (blood pressure \> 180/90 despite therapy)
* Uncontrolled diabetes mellitus defined by hemoglobin A1c \> 9
* Food allergies requiring strictly dietary adherence
* Pregnant or nursing women
* Chronic pancreatitis or history of recurring acute pancreatitis

Primary outcomes:
measure: Reduction of the M30 antigen in the serum
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Change in indicators of hepatocellular injury and fibrosis
timeFrame: 12 and 24 weeks
measure: Change in metabolic risk factors
timeFrame: 12 and 24 weeks
measure: Saftey and tolerability
timeFrame: 12 and 24 weeks
Other outcomes:
measure: Improvement in measures of nutritional physiology
timeFrame: 12 and 24 weeks
Locations:
city: Jena
country: Germany
facility: Institut für Ernährungswissenschaften, University Jena
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenber Univeristy
Study officials:
affiliation: Johannes Gutenberg Universität
name: Jörn M Schattenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universität Jena
name: Ina Bergheim, PhD
role: PRINCIPAL_INVESTIGATOR
References: