Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04201938 |
Other study ID # |
ENDO-5 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2018 |
Est. completion date |
January 15, 2019 |
Study information
Verified date |
June 2023 |
Source |
Bogomolets National Medical University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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
Description:
In this single-center double-blind, placebo controlled, parallel group study, 56 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.