Effect of Probiotic Co-administration With Omega-3 Fatty Acids on NAFLD
Condition: Type2 Diabetes; NAFLD; Probiotic; Omega-3 Fatty Acids
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      One of the potential ideal strategy for NAFLD treatment may be manipulation with gut
      microbiota. Probiotics are defined as live microorganisms that, when administered in adequate
      amounts, confer a health benefit on the host. Omega-3 fatty acids belong to the family of
      polyunsaturated fatty acids. They are known to exert a strong positive influence on
      metabolism and inflammation. The data from animal studies suggested that both probiotics and
      omega-3 can affect body weight, influence on glucose and fat metabolism, improve insulin
      sensitivity and reduce chronic systemic inflammation. In respect to experimental data, the
      current study aim was to provide double-blind single center RCT, for study the efficacy of
      co-administration of probiotic with omega-3 vs. placebo in type 2 diabetes patient with NAFLD
      detected on ultrasonography
    

Detailed description: 
      In this single-center double-blind, placebo controlled, parallel group study, 48 type 2
      diabetes patients from the Kyiv City Clinical Endocrinology Center were selected. They were
      randomly assigned to receive "Symbiter Omega" or placebo for 8 weeks, administered as a
      sachet formulation in double-blind treatment. Randomization was done by the study
      statistician based on a computer-generated list. The groups were homogeneous according to
      age, sex and diagnostic criteria. The assignment of groups was blind to participants,
      research staff and outcome assessors moreover, to maintain blind parallel study the
      statistician was not aware of the allocation of participants to intervention.

      The "Symbiter Omega" was supplied by Scientific and Production Company "O.D. Prolisok". It
      contains combination of flax and wheat germ oil (250 mg of each, concentration of omega-3
      fatty acids 1-5%), supplemented with biomass of 14 alive probiotic strains: Lactobacillus +
      Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g),
      Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1
      sachet (10 grams) of probiotic-omega and placebo per day. All sachets were identical with
      similar organoleptic characteristics (e.g., taste and appearance).

      The pre-randomization period was designed to minimize the effects of dietary changes on
      metabolic markers. For this purpose, 2 weeks before the study start, after inform consent
      signed, patients were instructed in one-on-one sessions with a dietitian to follow a
      therapeutic lifestyle-change diet as classiﬁed by the NCEP. In addition, participants were
      instructed to continue with stable anti-hyperglycemic treatment and received standardized
      mild physical training for 1 hour per day.

      Patients who underwent the study were instructed to take the trial medication as prescribed.
      Throughout the study, weekly phone follow-up visits were provided for assessment of
      compliance, adherence to the protocol, as well as the recording of adverse events. The
      effectiveness of therapy was compared and evaluated separately in the two groups.
    

Intervention name(s): Symbiter-Omega; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): "Symbiter Omega" which contains combination of flax and wheat germ oil (250 mg of each, concentration of omega-3 fatty acids 1-5%), supplemented with biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×101; Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment