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

Primary Purpose

Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Nutritional Counseling

Lactobacillus casei shirota (LCS)

Nutritional Counseling and LCS

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Histologically confirmed NASH, Hepatocyte Injury determined by M30 antigen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Institut für Ernährungswissenschaften, University Jena
University Medical Center of the Johannes Gutenber Univeristy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Nutritional Counseling

Nutritional Counseling and LCS

Lactobacillus Casei Shirota

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)

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.

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.

Full Information

NCT ID

NCT02366052

First Posted

November 1, 2013

Last Updated

May 15, 2017

Sponsor

Johannes Gutenberg University Mainz

Collaborators

University of Jena

1. Study Identification

Unique Protocol Identification Number

NCT02366052

Brief Title

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

Acronym

NucesNASH

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

February 1, 2015 (Actual)

Primary Completion Date

May 10, 2017 (Actual)

Study Completion Date

May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Johannes Gutenberg University Mainz

Collaborators

University of Jena

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic

Keywords

Histologically confirmed NASH, Hepatocyte Injury determined by M30 antigen

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nutritional Counseling

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Nutritional Counseling and LCS

Arm Type

Experimental

Arm Description

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.

Arm Title

Lactobacillus Casei Shirota

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Nutritional Counseling

Intervention Description

Nutritional counseling by a trained nutritionist for 12 weeks.

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactobacillus casei shirota (LCS)

Other Intervention Name(s)

Yakult plus

Intervention Description

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

Other

Intervention Name(s)

Nutritional Counseling and LCS

Other Intervention Name(s)

Nutritional Counseling and Yakult plus

Intervention Description

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

Primary Outcome Measure Information:

Title

Reduction of the M30 antigen in the serum

Description

Reduction of the M30 antigen as a validated measure of the degree of hepatocellular inflammation and injury

Time Frame

12 and 24 weeks

Secondary Outcome Measure Information:

Title

Change in indicators of hepatocellular injury and fibrosis

Description

Time Frame

12 and 24 weeks

Title

Change in metabolic risk factors

Description

Time Frame

12 and 24 weeks

Title

Saftey and tolerability

Description

Safety is assessed by (1) clinical examination, (2) clinical chemistries including serum electrolytes, renal, liver function tests and markers of pancreatic injury.

Time Frame

12 and 24 weeks

Other Pre-specified Outcome Measures:

Title

Improvement in measures of nutritional physiology

Description

Improvement of nutritional physiology, compliance, self-perceived efficacy, emotional eating behavior using a validated questionnaires.

Time Frame

12 and 24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jörn M Schattenberg, MD

Organizational Affiliation

Johannes Gutenberg Universität

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ina Bergheim, PhD

Organizational Affiliation

Universität Jena

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut für Ernährungswissenschaften, University Jena

City

Jena

ZIP/Postal Code

07743

Country

Germany

Facility Name

University Medical Center of the Johannes Gutenber Univeristy

City

Mainz

ZIP/Postal Code

55131

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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