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

NCT ID: NCT03585413

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2020-01-17

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.

Detailed Description

Background:

The increasing prevalence of obesity and diabetes mellitus seems to reach epidemic proportions worldwide. In particular visceral obesity in combination with impaired glucose tolerance is associated with risk for progression of a broad spectrum of cardiometabolic diseases such as type 2 diabetes, hypertension, dyslipidemia, cardiovascular disease and non-alcoholic fatty liver disease (NAFLD). Thus, among patients undergoing bariatric surgery more than 95% have NAFLD, with nonalcoholic steatohepatitis (NASH) being present in 32-39 %.

Only bariatric surgery currently seems to attain long-term weight loss in morbidly obese patients. In addition, greater success in terms of improvement in obesity related comorbidities and reduction of overall-mortality can be achieved by surgical measures. Recent data indicate that Mini-Gastric Bypass (MGB) is an effective procedure for weight loss and reduction of comorbidities. Although weight loss is usually recommended as therapy for obesity with NAFLD and NASH, not all NAFLD patients benefit from surgical induced weight loss as indicated by increase in transaminase activity. An optimized micronutrient in combination with a probiotic supplementation could be a useful tool to prevent the transition from NAFLD to NASH.

Aim:

Therefore this study aims to elucidate the effect of a specific micronutrient-probiotic-combination on fatty liver and insulin resistance in obese patients after MGB surgery. Furthermore, this study aims to help optimizing the dietary food supplementation after MGB to reduce the progress of NAFLD/NASH and cardiometabolic diseases.

Methods:

A randomized double blind clinical trial of 12 week dietary intervention with a specific micronutrient-probiotic-combination will be conducted in obese patients with NAFLD after standardized MGB surgery. To this end, a total of 60 patients will be randomly assigned to a specific micronutrient-probiotic-combination or micronutrient-placebo-combination group. During the preoperative 4-week run-in phase, each patient receives a formula diet to improve protein and micronutrient supply. This should align the metabolic situation within the study group. At baseline and study end blood samples are taken for further analysis of metabolic, clinical and biochemical parameters. Anthropometric data (body height, body weight, and waist circumference) and bioelectrical impedance analysis are also collected at the beginning and after 8 and 12 weeks. Fecal samples will be collected prior to surgery and after 4, 8 and 12 weeks (concomitant variable). All patients will fill out validated food intake questionnaires and stool questionnaires (frequency and consistence) after 4, 8 and 12 weeks (concomitant variable).

Conditions

Obesity; Gastric Bypass; NAFLD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Specific Micronutrient-probiotic-combination

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.

Group Type: ACTIVE_COMPARATOR

Micronutrient-probiotic-combination

Intervention Type: DIETARY_SUPPLEMENT

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

Micronutrient-placebo-combination

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.

Group Type: PLACEBO_COMPARATOR

Micronutrient-placebo-combination

Intervention Type: DIETARY_SUPPLEMENT

micronutrient (capsule)-placebo (powder)-supplement

Interventions

Micronutrient-probiotic-combination

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

Intervention Type: DIETARY_SUPPLEMENT

Micronutrient-placebo-combination

micronutrient (capsule)-placebo (powder)-supplement

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Franziskus Hospital

OTHER

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: collaborator

FormMed HealthCare AG

UNKNOWN

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Responsible Party

Karl Peter Rheinwalt

Scientific Adviser for Visceral- and Metabolic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karl Peter Rheinwalt, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

St. Franziskus-Hospital

Cologne, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 39339810 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34919684 (View on PubMed)

Other Identifiers

BFD-02/FMG-01

Identifier Type: -

Identifier Source: org_study_id