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Effect of Probiotic Co-administration With Omega-3 Fatty Acids on NAFLD

NCT03528707 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-12-17

No results posted yet for this study

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

Conditions

  • Type2 Diabetes
  • NAFLD
  • Probiotic
  • Omega-3 Fatty Acids

Interventions

DIETARY_SUPPLEMENT

Symbiter-Omega

"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

DIETARY_SUPPLEMENT

Placebo

Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day

Sponsors & Collaborators

  • Bogomolets National Medical University

    lead OTHER

Principal Investigators

  • Galyna Mykhalchyshyn, PhD · Bogomolets National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-14
Primary Completion
2015-12-22
Completion
2016-01-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528707 on ClinicalTrials.gov