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

NCT ID: NCT02366052

Last Updated: 2017-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2017-05-10

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.

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver, Nonalcoholic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Nutritional Counseling

Intervention Type: BEHAVIORAL

Nutritional counseling by a trained nutritionist for 12 weeks.

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.

Group Type: EXPERIMENTAL

Nutritional Counseling and LCS

Intervention Type: OTHER

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

Lactobacillus Casei Shirota

The dietary supplement LCS (Lactobacillus casei shirota ) will be given 2 times a day for 12 weeks.

Group Type: EXPERIMENTAL

Lactobacillus casei shirota (LCS)

Intervention Type: DIETARY_SUPPLEMENT

The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.

Interventions

Nutritional Counseling

Nutritional counseling by a trained nutritionist for 12 weeks.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIETARY_SUPPLEMENT

Nutritional Counseling and LCS

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

Intervention Type: OTHER

Other Intervention Names

Yakult plus; Nutritional Counseling and Yakult plus

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jena

OTHER

Sponsor Role: collaborator

Johannes Gutenberg University Mainz

OTHER

Sponsor Role: lead

Responsible Party

Priv.-Doz. Dr. J. Schattenberg

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jörn M Schattenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Johannes Gutenberg Universität

Ina Bergheim, PhD

Role: PRINCIPAL_INVESTIGATOR

Universität Jena

Locations

Institut für Ernährungswissenschaften, University Jena

Jena, , Germany

University Medical Center of the Johannes Gutenber Univeristy

Mainz, , Germany

Countries

Germany

Other Identifiers

SCHA 1015/5-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NUCES_NASH-JGU

Identifier Type: -

Identifier Source: org_study_id