Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03528707
Other study ID # ENDO-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 14, 2015
Est. completion date January 28, 2016

Study information

Verified date December 2019
Source Bogomolets National Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 28, 2016
Est. primary completion date December 22, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bogomolets National Medical University

References & 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) — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary liver stiffness (LS) liver stiffness (LS) was measured by Shear Wave Elastography (SWE) and expressed in kPa. 8 weeks compared to baseline
Secondary ALT ALT in IU/L 8 weeks compared to baseline
Secondary AST AST in IU/L 8 weeks compared to baseline
Secondary ?-GT ?-GT in IU/L 8 weeks compared to baseline
Secondary Total Cholesterol (TC) TC in mmol/l 8 weeks compared to baseline
Secondary Tryglicerides (TG) TG in mmol/l 8 weeks compared to baseline
Secondary LDL-Cholesterol (LDL-C) LDL-C in mmol/l 8 weeks compared to baseline
Secondary VLDL-Cholesterol (VLDL-C) VLDL-C in mmol/l 8 weeks compared to baseline
Secondary HDL-Cholesterol (HDL-C) HDL-C in mmol/l 8 weeks compared to baseline
Secondary cytokines levels TNF-a, IL-1ß, IL-6, IL-8, INF-? in pg/ml 8 weeks compared to baseline
See also
  Status Clinical Trial Phase
Recruiting NCT03239366 - A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes Population Phase 2
Completed NCT04597229 - Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus N/A
Completed NCT03623139 - Effects of Basic Carbohydrate Counting Versus Standard Outpatient Nutritional Education in Type 2 Diabetes N/A
Active, not recruiting NCT04599920 - Effects of Replacing Red Meat With Legumes on Biomarkers of Chronic Diseases in Healthy Men (Leg4Life) N/A
Active, not recruiting NCT03422471 - Hypoglycemia and Autonomic Nervous System Function- B2 N/A
Completed NCT04382521 - A Text Message Intervention to Promote Health Behaviors in Cardiac Risk Conditions N/A
Recruiting NCT04564391 - Whey or Casein - Liver Fat Reduction and Metabolic Improvement by Fast vs. Slow Proteins N/A
Recruiting NCT03458715 - The Efficacy of Sodium-glucose Co-transporter 2 Inhibitor or Dipeptidyl Peptidase-4 Inhibitor in Type 2 Diabetes Patients With Premix Insulin Phase 4
Terminated NCT03278236 - Does Time Restricted Feeding Improve Glycaemic Control in Overweight Men? N/A
Completed NCT02974504 - Phase IV Clinical Trial to Investigate the Effect on Blood Glucose of Evogliptin in Patients With Type 2 Diabetes(EVERGREEN) Phase 4
Completed NCT05053828 - Type 2 Diabetes With Antiplatelet Drugs
Not yet recruiting NCT03659383 - The Exploration of Optimal Treatment Scheme in Patients With Type 2 Diabetes Inadequately Controlled With Glargine Phase 4
Completed NCT03542240 - Effects of Curcumin Supplementation on Gut Barrier Function in Patients With Metabolic Syndrome N/A
Completed NCT03657537 - Effects of Ketone Bodies on Cognition in Type 2 Diabetes Phase 1
Completed NCT03979768 - Risk Assessment of Type 2 Diabetes in Pharmacies N/A
Completed NCT03614039 - Effect of Probiotic and Smectite Gel on NAFLD N/A
Active, not recruiting NCT04994288 - A Study of Efficacy and Safety of Supaglutide in Type 2 Diabetes Patients Phase 2/Phase 3
Completed NCT03290768 - Continuous Glucose Monitors to Regulate Glucose Levels in Type 2 Diabetics - (Protocol 3) N/A
Enrolling by invitation NCT04088851 - "The Role of the Liver for Interorgan Metabolic Crosstalk in Type 2 Diabetes" N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients