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Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery (FMG-01)

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ClinicalTrials.gov Identifier: NCT03585413
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
St. Franziskus Hospital
University of Bonn
FormMed HealthCare AG
Information provided by (Responsible Party):
Karl Peter Rheinwalt, Bonn Education Association for Dietetics r.A., Cologne, Germany

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.

Condition or disease Intervention/treatment Phase
Obesity Gastric Bypass NAFLD Dietary Supplement: Micronutrient-probiotic-combination Dietary Supplement: Micronutrient-placebo-combination Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective, randomized, placebo-controlled, double-blind interventional study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of a Specific Micronutrient-probiotic-combination on Fatty Liver and Cardiometabolic Status of Obese Patients After Mini-Gastric Bypass Surgery
Actual Study Start Date : August 31, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.

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.

Placebo Comparator: 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.

Dietary Supplement: Micronutrient-placebo-combination
micronutrient (capsule)-placebo (powder)-supplement




Primary Outcome Measures :
  1. Change in alanine-aminotransferase (ALAT) activity in serum [ Time Frame: Baseline and 12 weeks ]
    ALAT in U/l


Secondary Outcome Measures :
  1. Change in Fatty Liver Index (FLI) [ Time Frame: Baseline and 12 weeks ]

    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.


  2. Change in nonalcoholic fatty liver disease (NAFLD) Fibrosis Score (NFS) [ Time Frame: Baseline and 12 weeks ]

    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.


  3. Change in fasting glucose concentration [ Time Frame: Baseline and 12 weeks ]
    Fasting glucose in mmol/l

  4. Change in fasting insulin concentration [ Time Frame: Baseline and 12 weeks ]
    Fasting insulin in pmol/l

  5. Change in homeostatic model assessment (HOMA) of insulin resistance (IR) (HOMA-IR) [ Time Frame: Baseline and 12 weeks ]

    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.


  6. Change in glycated haemoglobin (HbA1c) [ Time Frame: Baseline and 12 weeks ]
    Intervention change in HbA1c level

  7. Change in resting blood pressure [ Time Frame: Baseline and 12 weeks ]
    Intervention changes in resting blood pressure in mmHg

  8. Change in heart rate [ Time Frame: Baseline and 12 weeks ]
    Intervention changes in heart rate in bpm



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585413


Contacts
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Contact: Silke Crommen +49 221 5591 ext 4335 s.crommen@uni-bonn.de

Locations
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Germany
St. Franziskus-Hospital Recruiting
Cologne, Germany, 50825
Sponsors and Collaborators
Bonn Education Association for Dietetics r.A., Cologne, Germany
St. Franziskus Hospital
University of Bonn
FormMed HealthCare AG
Investigators
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Principal Investigator: Karl Peter Rheinwalt, MD St. Franziskus Hospital, Cologne and Bonn Education Association for Dietetics r.A., Cologne, Germany

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Responsible Party: Karl Peter Rheinwalt, Scientific Adviser for Visceral- and Metabolic Surgery, Bonn Education Association for Dietetics r.A., Cologne, Germany
ClinicalTrials.gov Identifier: NCT03585413     History of Changes
Other Study ID Numbers: BFD-02/FMG-01
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: n.a.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karl Peter Rheinwalt, Bonn Education Association for Dietetics r.A., Cologne, Germany:
Bariatric surgery
Obesity
NAFLD
Micronutrient supplementation
Probiotic supplementation

Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases
Vitamins
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs