NCT02366052

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-05-10
• Completion: 2017-05-10
• First posted: 2015-02-19
• Last updated: 2017-05-16

Locations

2 sites across 1 country: Germany