- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03528707
Effect of Probiotic Co-administration With Omega-3 Fatty Acids on NAFLD
Effect of Probiotic Co-administration With Omega-3 Fatty Acids on NAFLD: Randomized Clinical Studies
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: probiotic-omega
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day.
|
"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
|
PLACEBO_COMPARATOR: placebo
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
|
Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fatty liver index (FLI)
Time Frame: 8 weeks compared to baseline
|
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)
Time Frame: 8 weeks compared to baseline
|
liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa.
|
8 weeks compared to baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ALT
Time Frame: 8 weeks compared to baseline
|
ALT in IU/L
|
8 weeks compared to baseline
|
AST
Time Frame: 8 weeks compared to baseline
|
AST in IU/L
|
8 weeks compared to baseline
|
γ-GT
Time Frame: 8 weeks compared to baseline
|
γ-GT in IU/L
|
8 weeks compared to baseline
|
Total Cholesterol (TC)
Time Frame: 8 weeks compared to baseline
|
TC in mmol/l
|
8 weeks compared to baseline
|
Tryglicerides (TG)
Time Frame: 8 weeks compared to baseline
|
TG in mmol/l
|
8 weeks compared to baseline
|
LDL-Cholesterol (LDL-C)
Time Frame: 8 weeks compared to baseline
|
LDL-C in mmol/l
|
8 weeks compared to baseline
|
VLDL-Cholesterol (VLDL-C)
Time Frame: 8 weeks compared to baseline
|
VLDL-C in mmol/l
|
8 weeks compared to baseline
|
HDL-Cholesterol (HDL-C)
Time Frame: 8 weeks compared to baseline
|
HDL-C in mmol/l
|
8 weeks compared to baseline
|
cytokines levels
Time Frame: 8 weeks compared to baseline
|
TNF-α, IL-1β, IL-6, IL-8, INF-γ in pg/ml
|
8 weeks compared to baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Galyna Mykhalchyshyn, PhD, Bogomolets National Medical University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDO-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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