Nutritional Counseling vs. Nutritional Supplements for NASH - a Randomized Prospective, Open Label Pilot Study

Phase 2

Completed

• Conditions: Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic
• Interventions: Behavioral: Nutritional Counseling; Other: Nutritional Counseling and LCS; Dietary Supplement: Lactobacillus casei shirota (LCS)

• Registration Number: NCT02366052
• Lead Sponsor: Johannes Gutenberg University Mainz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-01
• Study Start: 2015-02-01
• Study First Submitted QC: 2015-02-11
• Study First Posted: 2015-02-19
• Status Verified: 2017-05
• Primary Completion: 2017-05-10
• Study Completion: 2017-05-10
• Last Update Submitted: 2017-05-15
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutritional Counseling	Nutritional Counseling	The nutritional counseling group will receive dietary counseling focusing on a reduction of fructose intake by a trained nutritionist for 12 weeks every 3 weeks.
Nutritional Counseling and LCS	Nutritional Counseling and LCS	The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks in addition to the nutritional counseling every 3 weeks.
Lactobacillus Casei Shirota	Lactobacillus casei shirota (LCS)	The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction of the M30 antigen in the serum	12 and 24 weeks	Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury

Secondary Outcome Measures

Name	Time	Method
Saftey and tolerability	12 and 24 weeks	Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.
Change in indicators of hepatocellular injury and fibrosis	12 and 24 weeks	Change in indicators of hepatocellular injury (ALT, gammaGT, M30/M60 antigen ratio, ELF score), proinflammatory cytokines (hsCRP, ferritin, plasminogen activator-1, endotoxin), surrogate parameters of liver fibrosis (fibrosis marker panels, Fibrotest, ELF score) and relative liver stiffness (assessed by Fibro Scan)
Change in metabolic risk factors	12 and 24 weeks	Changes in metabolic risk factors (BMI, waist circumference, Homeostasis Model Assessment/Matsuda Score, serum lipids), changes in oral glucose tolerance and changes in hepatic steatosis will be assessed.

Trial Locations

Locations (2)

University Medical Center of the Johannes Gutenber Univeristy; 🇩🇪 Mainz, Germany

Institut für Ernährungswissenschaften, University Jena; 🇩🇪 Jena, Germany