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Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery

NCT03585413 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-25

No results posted yet for this study

Summary

Aim of this prospective randomized intervention study is to evaluate the effect of a dietary intervention with a specific micronutrient-probiotic-combination for 12 weeks on fatty liver and cardiometabolic status in obese, nonalcoholic fatty liver disease (NAFLD) patients after Mini-Gastric Bypass (MGB) surgery.

Conditions

Interventions

DIETARY_SUPPLEMENT

Micronutrient-probiotic-combination

Specific combined micronutrient-probiotic-supplement with different vitamins, minerals, phytochemicals and bioactive substances, and a mixture of 10 different probiotic bacteria.

DIETARY_SUPPLEMENT

Micronutrient-placebo-combination

micronutrient (capsule)-placebo (powder)-supplement

Sponsors & Collaborators

  • St. Franziskus Hospital

    collaborator OTHER

  • University of Bonn

    collaborator OTHER

  • FormMed HealthCare AG

    collaborator UNKNOWN

  • Bonn Education Association for Dietetics r.A., Cologne, Germany

    lead INDUSTRY

Principal Investigators

  • Karl Peter Rheinwalt, MD · St. Franziskus Hospital, Cologne and Bonn Education Association for Dietetics r.A., Cologne, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2020-01-17
Completion
2020-01-17

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03585413 on ClinicalTrials.gov