Impact of a Specific Micronutrient-probiotic-supplement on Fatty Liver of Patients After Mini-Gastric Bypass Surgery
Condition: Obesity; Gastric Bypass; NAFLD
MeSH terms: Fatty Liver
Study type: Interventional
Phase: Phase 3

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).
    

Intervention name(s): Micronutrient-probiotic-combination; Micronutrient-placebo-combination
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Specific combined micronutrient-probiotic-supplement with different vitamins, minerals, phytochemicals and bioactive substances, and a mixture of 10 different probiotic bacteria.; micronutrient (capsule)-placebo (powder)-supplement
Intervention MeSH terms: Micronutrients; Trace Elements
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
Keywords: Bariatric surgery; Obesity; NAFLD; Micronutrient supplementation; Probiotic supplementation