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

Non-alcoholic Fatty Liver Disease Clinical Trial

— NucesNASH  

Official title:

Nutritional Counseling Versus Nutritional Supplements for the Treatment of NASH - a Randomized Prospective, Open Label Pilot Study (Nuces NASH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366052
• Other study ID #: NUCES_NASH-JGU
• Secondary ID: SCHA 1015/5-1
• Status: Completed
• Phase: Phase 2
• First received: November 1, 2013
• Last updated: May 15, 2017
• Start date: February 1, 2015
• Est. completion date: May 10, 2017

Study information

• Verified date: May 2017
• Source: Johannes Gutenberg University Mainz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 10, 2017
• Est. primary completion date: May 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Nonalcoholic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Behavioral:
• Nutritional Counseling
Nutritional counseling by a trained nutritionist for 12 weeks.

Dietary Supplement:
• Lactobacillus casei shirota (LCS)
The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.

Other:
• Nutritional Counseling and LCS
Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.

Locations

Country	Name	City	State
Germany	Institut für Ernährungswissenschaften, University Jena	Jena
Germany	University Medical Center of the Johannes Gutenber Univeristy	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Improvement in measures of nutritional physiology	Improvement of nutritional physiology, compliance, self-perceived efficacy, emotional eating behavior using a validated questionnaires.	12 and 24 weeks
Primary	Reduction of the M30 antigen in the serum	Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury	12 and 24 weeks
Secondary	Change in indicators of hepatocellular injury and fibrosis	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)	12 and 24 weeks
Secondary	Change in metabolic risk factors	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.	12 and 24 weeks
Secondary	Saftey and tolerability	Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.	12 and 24 weeks