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

NCT03528707 | Completed

• 1 other identifier: ENDO-2
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• fatty liver index (FLI)

  FLI = \[e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745) / (1 + e 0.953\*loge (triglycerides) + 0.139\*BMI + 0.718\*loge (ggt) + 0.053\*waist circumference - 15.745)\] × 100

  8 weeks compared to baseline

• liver stiffness (LS)

  liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa.

  8 weeks compared to baseline

Secondary Outcomes (9)

• ALT

  8 weeks compared to baseline

• AST

  8 weeks compared to baseline

• γ-GT

  8 weeks compared to baseline

• Total Cholesterol (TC)

  8 weeks compared to baseline

• Tryglicerides (TG)

  8 weeks compared to baseline

Study Arms (2)

probiotic-omega

ACTIVE COMPARATOR

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

Dietary Supplement: Symbiter-Omega

placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Symbiter-Omega DIETARY_SUPPLEMENT

"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

probiotic-omega

Placebo DIETARY_SUPPLEMENT

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

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult participants (ages 18-75, BMI ≥25 kg/m2) diagnosed with NAFLD according to the recommendations of the American Gastroenterology Association (AGA) and American Association for the Study of Liver Disease (AASLD);
• the diagnosis of fatty liver was based on the results of abdominal ultrasonography. Of 4 known criteria (hepato-renal echo contrast, liver brightness, deep attenuation, and vascular blurring), the participants were required to have hepato-renal contrast and liver brightness to be given a diagnosis of NAFLD.
• type 2 diabetes treated with diet and exercise alone or metformin, SUs and insulin at stable dose at least 4 weeks prior to the commencement of the study;
• AST and ALT ≤3x upper limit of normal.

You may not qualify if:

• alcohol abuse (\>20 g/day (2 standard drinks) in women or \> 30 g/d (3 drinks) in men over a two-year period);
• chronic viral hepatitis (associated with HBV, HCV, HDV infection);
• drug-induced liver disease, Wilson's disease, hereditary deficiency of antitrypsin-1 and idiopathic hemochromatosis;
• history of decompensated liver disease including ascites, encephalopathy or variceal bleeding;
• regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment;
• antibiotic use within 3 months prior to enrollment;
• uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections;
• use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, GLP-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid);
• and presence of active infection, pregnancy or lactation.

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Related Publications (1)

• Kobyliak N, Abenavoli L, Falalyeyeva T, Mykhalchyshyn G, Boccuto L, Kononenko L, Kyriienko D, Komisarenko I, Dynnyk O. Beneficial effects of probiotic combination with omega-3 fatty acids in NAFLD: a randomized clinical study. Minerva Med. 2018 Dec;109(6):418-428. doi: 10.23736/S0026-4806.18.05845-7. Epub 2018 Sep 13.

  PMID: 30221912 RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Galyna Mykhalchyshyn, PhD

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology Department, PhD

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 18, 2018
• Study Start: April 14, 2015
• Primary Completion: December 22, 2015
• Study Completion: January 28, 2016
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share