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

Obesity Clinical Trial

— FMG-01  

Official title:

Impact of a Specific Micronutrient-probiotic-combination on Fatty Liver and Cardiometabolic Status of Obese Patients After Mini-Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585413
• Other study ID #: BFD-02/FMG-01
• Status: Completed
• Phase: Phase 3
• Start date: August 31, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: September 2020
• Source: Bonn Education Association for Dietetics r.A., Cologne, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Gastric Bypass
• NAFLD
• Obesity

Intervention

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.
• Micronutrient-placebo-combination
micronutrient (capsule)-placebo (powder)-supplement

Locations

Country	Name	City	State
Germany	St. Franziskus-Hospital	Cologne

Sponsors (4)

Lead Sponsor	Collaborator
Bonn Education Association for Dietetics r.A., Cologne, Germany	FormMed HealthCare AG, St. Franziskus Hospital, University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alanine-aminotransferase (ALAT) activity in serum	ALAT in U/l	Baseline and 12 weeks
Secondary	Change in Fatty Liver Index (FLI)	FLI will be calculated as: [e 0.953 x loge (triglycerides (mg/dl)) + 0.139 x BMI (kg/m²) + 0.718 x loge (GGT (U/l)) + 0.053 x waist circumference (cm) - 15.745) / (1 + e 0.953 x loge (triglycerides (mg/dl)) + 0.139 x BMI (kg/m²) + 0.718 x loge (GGT (U/l)) + 0.053 x waist circumference (cm) - 15.745)] × 100.; A FLI < 30 rules out fatty liver and a FLI > 60 rules in fatty liver.	Baseline and 12 weeks
Secondary	Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS)	NFS will be calculated as: - 1.675 + 0.037 x age (years) + 0.094 x BMI (kg/m²) + 1.13 x impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 x aspartate aminotransferase (ASAT)/ALAT ratio - 0.013 x platelet (x10^9) - 0.66 x albumin (g/dl).; NFS > 0.676 is considered to be diagnostic for the presence of significant fibrosis.; NFS < -1.455 is considered to be diagnostic fot the absence if fibrosis. NFS scores between -1.455 and 0.675 are referred as "indeterminate" scores.	Baseline and 12 weeks
Secondary	Change in fasting glucose concentration	Fasting glucose in mmol/l	Baseline and 12 weeks
Secondary	Change in fasting insulin concentration	Fasting insulin in pmol/l	Baseline and 12 weeks
Secondary	Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR)	HOMA-IR will be calculated as: fasting insulin (µU/ml) x fasting glucose (mmol/l) / 22.5.; HOMA-IR > 2.77 is considered to be diagnostic for insulin resistance.	Baseline and 12 weeks
Secondary	Change in glycated haemoglobin (HbA1c)	Intervention change in HbA1c level	Baseline and 12 weeks
Secondary	Change in resting blood pressure	Intervention changes in resting blood pressure in mmHg	Baseline and 12 weeks
Secondary	Change in heart rate	Intervention changes in heart rate in bpm	Baseline and 12 weeks