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

NCT02366052 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2017-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Jena

    collaborator OTHER

  • Johannes Gutenberg University Mainz

    lead OTHER

Principal Investigators

  • Jörn M Schattenberg, MD · Johannes Gutenberg Universität

  • Ina Bergheim, PhD · Universität Jena

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-01
Primary Completion
2017-05-10
Completion
2017-05-10

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02366052 on ClinicalTrials.gov