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

NCT03585413 | Completed Phase 3 DMC

• 1 other identifier: BFD-02/FMG-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Gastric Bypass; NAFLD

Keywords

Bariatric surgery; Obesity; NAFLD; Micronutrient supplementation; Probiotic supplementation

Outcome Measures

Primary Outcomes (1)

• Change in alanine-aminotransferase (ALAT) activity in serum

  ALAT in U/l

  Baseline and 12 weeks

Secondary Outcomes (8)

• Change in Fatty Liver Index (FLI)

  Baseline and 12 weeks

• Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS)

  Baseline and 12 weeks

• Change in fasting glucose concentration

  Baseline and 12 weeks

• Change in fasting insulin concentration

  Baseline and 12 weeks

• Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR)

  Baseline and 12 weeks

Study Arms (2)

Specific Micronutrient-probiotic-combination

ACTIVE COMPARATOR

Intake of one micronutrient capsule three times daily and probiotic powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively. The micronutrient capsules consist of vitamins, minerals, phytochemicals and bioactive substances. The probiotic supplement is a powder of 10 different species of probiotic bacteria.

Dietary Supplement: Micronutrient-probiotic-combination

Micronutrient-placebo-combination

PLACEBO COMPARATOR

Intake of one micronutrient capsule three times daily and placebo powder twice daily starting on the first day after hospital discharge until 12 weeks postoperatively. The micronutrient-control-combination consists of a micronutrient capsule (vitamins and minerals) but without phytochemicals and bioactive substances, and a placebo powder manufactured to mimic the probiotic powder.

Dietary Supplement: Micronutrient-placebo-combination

Interventions

Micronutrient-probiotic-combination DIETARY_SUPPLEMENT

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

Specific Micronutrient-probiotic-combination

Micronutrient-placebo-combination DIETARY_SUPPLEMENT

micronutrient (capsule)-placebo (powder)-supplement

Micronutrient-placebo-combination

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects 20-65 years old
• BMI ≥ 35 kg/m² to ≤ 50 kg/m²
• Fatty Liver Index ≥ 60

You may not qualify if:

• subjects with anamnestic known alcoholic-fatty liver disease, hepatitis B, hepatitis C, HIV/ AIDS
• subjects with chronic conditions such as active malignant disease, inflammatory bowel disease and other systemic inflammatory conditions
• supplementation with dietary supplements or drugs which contain probiotics, milk thistle, fatty acids, vitamins or minerals 4 weeks before bariatric surgery
• treatment with psychotropic drugs
• diabetic patients who are treated with antidiabetic medications
• use of antibiotic 4 weeks before bariatric surgery
• weight gain during run-in phase of more than 5 %
• in women of childbearing age, pregnancy or breastfeeding
• no safe method of contraception in women of childbearing age

Sponsors & Collaborators

• Bonn Education Association for Dietetics r.A., Cologne, Germany: lead
• St. Franziskus Hospital: collaborator
• University of Bonn: collaborator
• FormMed HealthCare AG: collaborator

Study Sites (1)

St. Franziskus-Hospital

Cologne, 50825, Germany

Location

Related Publications (2)

• Crommen S, Rheinwalt KP, Plamper A, Rosler D, Weinhold L, Metzner C, Egert S. Prognostic Characteristics of Metabolic Dysfunction-Associated Steatotic Liver in Patients with Obesity Who Undergo One Anastomosis Gastric Bypass Surgery: A Secondary Analysis of Randomized Controlled Trial Data. Nutrients. 2024 Sep 23;16(18):3210. doi: 10.3390/nu16183210.

  PMID: 39339810 DERIVED

• Crommen S, Rheinwalt KP, Plamper A, Simon MC, Rosler D, Fimmers R, Egert S, Metzner C. A Specifically Tailored Multistrain Probiotic and Micronutrient Mixture Affects Nonalcoholic Fatty Liver Disease-Related Markers in Patients with Obesity after Mini Gastric Bypass Surgery. J Nutr. 2022 Feb 8;152(2):408-418. doi: 10.1093/jn/nxab392.

  PMID: 34919684 DERIVED

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Karl Peter Rheinwalt, MD

  St. Franziskus Hospital, Cologne and Bonn Education Association for Dietetics r.A., Cologne, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Adviser for Visceral- and Metabolic Surgery

Model Details: prospective, randomized, placebo-controlled, double-blind interventional study

Study Record Dates

• First Submitted: June 7, 2018
• First Posted: July 13, 2018
• Study Start: August 31, 2018
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)