Effect of Probiotic Co-administration With Omega-3 Fatty Acids on Obesity Parameters and Insulin Resistance

NCT04201938 | Completed

• 1 other identifier: ENDO-5
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Obesity; Insulin Resistance; Insulin Sensitivity; Type2 Diabetes; Visceral Obesity

Keywords

Omega-3 Fatty Acids; Probiotic; Lactobacillus; Bifidobacterium; Propionibacterium; Acetobacter; Obesity; Type2 Diabetes; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• HOMA-2IR

  This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php

  8 weeks compared to baseline

• insulin sensitivity (%S)

  This model can be calculated using the software supplied by the Oxford Centre for Diabetes Endocrinology and Metabolism available at http://www.dtu.ox.ac.uk/homacalculator/index.php

  8 weeks compared to baseline

Secondary Outcomes (9)

• HbA1c

  8 weeks compared to baseline

• fasting plasma insulins (FPI)

  8 weeks compared to baseline

• fasting plasma glucose (FPG)

  8 weeks compared to baseline

• β-cell function (%B)

  8 weeks compared to baseline

• C-peptide

  8 weeks compared to baseline

Study Arms (2)

Symbiter-Omega

ACTIVE COMPARATOR

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

Combination Product: 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 COMBINATION_PRODUCT

Symbiter-Omega 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.

Symbiter-Omega

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 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)
• presence of T2D diagnosed according to criteria of the American Diabetes Association (fasting plasma glucose (FPG)≥7.0mmol/l, random plasma glucose ≥11.1mmol/l, HbA1c ≥6.5%, or glucose higher than 11.1mmol/l 2 hours after a 75-g oral glucose load);
• T2D duration at least 6 months prior to the study;
• patient who treated with diet and exercise alone or metformin, SUs and insulin on a stabilized dose for at least 3 months before the study;
• presence of insulin resistance established as HOMA-2IR≥2.0;
• HbA1c between 6.5 and 11.0 %;
• written informed consent.

You may not qualify if:

• presence of type 1 diabetes;
• regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment; antibiotic use within 3 months prior to enrollment;
• allergy on probiotics or their components;
• presence of gastrointestinal diseases such as food allergy, celiac disease, non-specific ulcerative colitis;
• uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;
• participation in other clinical trials;
• presence of pregnancy or lactation.

Sponsors & Collaborators

• Bogomolets National Medical University: lead
• Taras Shevchenko National University of Kyiv: collaborator

Study Sites (1)

Bogomolets National Medical University

Kyiv, 01601, Ukraine

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Nazarii Kobyliak, 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, Endocrinology Department

Study Record Dates

• First Submitted: December 15, 2019
• First Posted: December 17, 2019
• Study Start: February 1, 2018
• Primary Completion: March 1, 2018
• Study Completion: January 15, 2019
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)