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

NCT02366052 | Completed Phase 2 DMC

• 2 other identifiers: NUCES_NASH-JGUSCHA 1015/5-1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 2

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

Keywords

Histologically confirmed NASH; Hepatocyte Injury determined by M30 antigen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in indicators of hepatocellular injury and fibrosis

  12 and 24 weeks

• Change in metabolic risk factors

  12 and 24 weeks

• Saftey and tolerability

  12 and 24 weeks

Other Outcomes (1)

• Improvement in measures of nutritional physiology

  12 and 24 weeks

Study Arms (3)

Nutritional Counseling

ACTIVE COMPARATOR

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.

Behavioral: Nutritional Counseling

Nutritional Counseling and LCS

EXPERIMENTAL

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.

Other: Nutritional Counseling and LCS

Lactobacillus Casei Shirota

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus casei shirota (LCS)

Interventions

Nutritional Counseling BEHAVIORAL

Nutritional counseling by a trained nutritionist for 12 weeks.

Nutritional Counseling

Lactobacillus casei shirota (LCS) 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.

Also known as: Yakult plus

Lactobacillus Casei Shirota

Nutritional Counseling and LCS OTHER

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

Also known as: Nutritional Counseling and Yakult plus

Nutritional Counseling and LCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• University of Jena: collaborator

Study Sites (2)

Institut für Ernährungswissenschaften, University Jena

Jena, 07743, Germany

Location

University Medical Center of the Johannes Gutenber Univeristy

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jörn M Schattenberg, MD

  Johannes Gutenberg Universität

  PRINCIPAL INVESTIGATOR

• Ina Bergheim, PhD

  Universität Jena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: February 19, 2015
• Study Start: February 1, 2015
• Primary Completion: May 10, 2017
• Study Completion: May 10, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

DE (2)