ObesityNCT05770076
Probiotic Lysate (Postbiotic and Metabiotic) Supplementation for Type 2 Diabetes Patients (DELI_Diab Study)
A study testing Probiotic lysate (postbiotic and metabiotic) in people with Obesity and Obesity, Abdominal, run by Bogomolets National Medical University at 4 sites in Ukraine.
Trial summary
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Obesity, Abdominal, Insulin Resistance
- What is being tested?
- Probiotic lysate (postbiotic and metabiotic)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 4 sitesUkraine
- Study dates
- 1 Feb 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult participants (ages 18-70)
- presence of T2D diagnosed according to criteria of the American Diabetes Association;
- BMI 25-40 kg/m2;
- 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;
- daily insulin dosage less than 60IU;
- HbA1c between 6.5 and 10.0 %;
- written informed consent.
Who cannot join
- presence of type 1 diabetes;
- severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
- treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, SGLT-2 antagonists, GLP-1 analogues, DPP IV inhibitors etc);
- regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) 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;
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- uncontrolled cardiovascular or respiratory disease, decompensated liver disease including ascites, encephalopathy or variceal bleeding, active malignancy, or chronic infections;
- participant who had severe course of COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks prior to enrollment;
- participation in other clinical trials;
- presence of pregnancy or lactation.
Trial locations and contacts
4 sites in 1 country.
Ukraine4 sites
Bogomolets National Medical University
Kyiv, 01601
Kyiv City Clinical Endocrinology Center
Kyiv, 01601
Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine
Kyiv, 02000
Danylo Halytsky Lviv National Medical University
Lviv, 79010
About this study
Official title: Effect of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation on Metabolic Parameters in Type 2 Diabetes Patients
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.
Read the detailed description
The scientific literature points to the beneficial properties of probiotics in the process of regulating metabolism, yet at the same time, some scientific papers question the effectiveness and the safety of probiotics. In turn, postbiotics and metabiotics are preparations of inanimate microorganisms and / or their components, which are directly identified with the safety of their use and the health benefits of the host. Due to the chemical structure of postbiotics and metabiotics, it is found that they have many health benefits; in particular, they have a local effect on certain tissues of the intestinal epithelium, and influence on many other organs and tissues. It is postbiotics metabolites and metabiotics structural cell fragments that create the appearance of a therapeutic effect of probiotics, which, in turn, limits the risk of introducing living microorganisms into a weakened immune defence. It should also be pointed out that postbiotics and metabiotics are more stable and have a longer shelf-life.
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates, which are the natural mixes of metabiotic and postbiotic substances; a biological activity which is strongly oriented toward gut health and immune system regulation. Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells, one of the future goal is research of the novel postbiotics and metabiotics substances, their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives.
Considering the high biological activity and safety of postbiotics and metabiotic substances, it can be concluded that such a treatment vector will be promising in the near future. That's why our investigation will concentrate on postbiotic, a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023.
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders. The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. All capsules will be identical with similar organoleptic characteristics (e.g., taste and appearance).. Follow-up period of up to 3 month.
The pre-randomization period will be 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.
- Conditions
- Obesity, Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity, Type2 Diabetes, Type 2 Diabetes Mellitus in Obese
- Being tested
- Probiotic lysate (postbiotic and metabiotic), Placebo
- Keywords
- Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Type2 Diabetes, Insulin Resistance
- Medical subject headings
- Obesity, Obesity, Abdominal, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic lysate (postbiotic and metabiotic)Dietary supplement
Also called Del-Immune V® Extra
Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotic) group | Active comparator | oral, 2 capsules per day (BID) for 3 month treatment Receives: Dietary Supplement: Probiotic lysate (postbiotic and metabiotic) |
| Placebo group | Placebo comparator | placebo, oral, 2 capsules per day (BID) for 3 month treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c level
HbA1c in %
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Changes in fasting plasma glucose (FPG) level
FPG in mmol/L
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Secondary outcomes (8)
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
Measured: at 3 month (end of treatment) and 6 month (follow-up period) 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
[Time Frame: 8 weeks compared to baseline]
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
β-cell function (%B)
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
[Time Frame: 8 weeks compared to baseline]
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
C-peptide
C-peptide, ng/ml
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
High censitivity CRP (C-reactive Protein)
hs-CRP in mg/L
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
weight
weight in kg
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
waist circumferences (WC)
WC in cm
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body mass index (BMI)
weight in kg and height in meters will be combined to report BMI in kg/m^2
Measured: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Feb 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, Kyiv City Clinical Endocrinology Center, MirImmunoFarm, Stellar Biotics
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
- Investigators
- Nazarii Kobyliak, PhD, Principal investigator, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770076
- Sponsor's protocol ID
- DELI_Diab
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Savytska M, Baka O, Manzhalii E, Kyriienko D, Falalyeyeva T, Strubchevska O, Futornyi S, Pastukhova V, Lukyantseva H, Sichel L, Kobyliak N. Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study). Front Endocrinol (Lausanne). 2026 May 4;17:1802045. doi: 10.3389/fendo.2026.1802045. eCollection 2026.
PubMed 42158917
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation on Metabolic Parameters in Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT05770076
- Acronym / sponsor ID
- DELI_Diab
- Conditions
- Obesity, Obesity, Abdominal, Insulin Resistance, Insulin Sensitivity, Type2 Diabetes, Type 2 Diabetes Mellitus in Obese
- Keywords
- Postbiotics, metabiotics, L. rhamnosus, L. delbrueckii, Obesity, Type2 Diabetes, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Collaborators
- Taras Shevchenko National University of Kyiv, Danylo Halytsky Lviv National Medical University, Center for Innovative Medical Technologies of the National Academy of Sciences of Ukraine, Kyiv City Clinical Endocrinology Center, MirImmunoFarm, Stellar Biotics
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.
Detailed description
The scientific literature points to the beneficial properties of probiotics in the process of regulating metabolism, yet at the same time, some scientific papers question the effectiveness and the safety of probiotics. In turn, postbiotics and metabiotics are preparations of inanimate microorganisms and / or their components, which are directly identified with the safety of their use and the health benefits of the host. Due to the chemical structure of postbiotics and metabiotics, it is found that they have many health benefits; in particular, they have a local effect on certain tissues of the intestinal epithelium, and influence on many other organs and tissues. It is postbiotics metabolites and metabiotics structural cell fragments that create the appearance of a therapeutic effect of probiotics, which, in turn, limits the risk of introducing living microorganisms into a weakened immune defence. It should also be pointed out that postbiotics and metabiotics are more stable and have a longer shelf-life.
The practical use of probiotics and the study of the mechanism of their action made lately to find that a certain level of biological activity is preserved by dead probiotic cells and even their lysates, which are the natural mixes of metabiotic and postbiotic substances; a biological activity which is strongly oriented toward gut health and immune system regulation. Because probiotic lysates demonstrated biological activity without any of the potential adverse side effects associated with live bacterial cells, one of the future goal is research of the novel postbiotics and metabiotics substances, their individual structures and biological characteristics for understanding their way of communications with host cells and microbiota representatives.
Considering the high biological activity and safety of postbiotics and metabiotic substances, it can be concluded that such a treatment vector will be promising in the near future. That's why our investigation will concentrate on postbiotic, a supplement containing dry fermented cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023.
Recent scientific animal studies on the stated issues point to the benefits of some postbiotics in treating metabolic disorders. The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients.
The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. All capsules will be identical with similar organoleptic characteristics (e.g., taste and appearance).. Follow-up period of up to 3 month.
The pre-randomization period will be 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotic) group | Active comparator | Dietary Supplement: Probiotic lysate (postbiotic and metabiotic)oral, 2 capsules per day (BID) for 3 month treatment |
| Placebo group | Placebo comparator | Dietary Supplement: Placeboplacebo, oral, 2 capsules per day (BID) for 3 month treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- adult participants (ages 18-70)
- presence of T2D diagnosed according to criteria of the American Diabetes Association;
- BMI 25-40 kg/m2;
- 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;
- daily insulin dosage less than 60IU;
Key exclusion criteria (10 listed)
- presence of type 1 diabetes;
- severe diabetes-related complications at screening (ie, end-stage DKD, neuropathy requiring pharmacological treatment, proliferative retinopathy, autonomic neuropathy);
- treatment with other than mention in inclusion criteria antidiabetic drugs (pioglitazone, SGLT-2 antagonists, GLP-1 analogues, DPP IV inhibitors etc);
- regular use of an agents with gut microbiota modulation activity (antibiotic, pro-, pre-, post or synbiotics supplement etc.) within 3 months prior to enrollment;
- allergy on probiotics or their components;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic lysate (postbiotic and metabiotic)Also: Del-Immune V® ExtraEach capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder | Dietary supplement | Probiotic lysate (postbiotic and metabiotic) group |
| PlaceboPlacebo | Dietary supplement | Placebo group |
Primary outcome
Changes in HbA1c level
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
HbA1c in %
Changes in fasting plasma glucose (FPG) level
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
FPG in mmol/L
8 secondary outcomes
HOMA-2IR
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
insulin sensitivity (%S)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
β-cell function (%B)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
C-peptide
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
High censitivity CRP (C-reactive Protein)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
weight
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
waist circumferences (WC)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
body mass index (BMI)
Time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 42158917Savytska M, Baka O, Manzhalii E, Kyriienko D, Falalyeyeva T, Strubchevska O, Futornyi S, Pastukhova V, Lukyantseva H, Sichel L, Kobyliak N. Effect of probiotics derivatives (postbiotics and metabiotics) on glycemic control in individuals with type 2 diabetes: a randomized clinical trial (DELI_Diab study). Front Endocrinol (Lausanne). 2026 May 4;17:1802045. doi: 10.3389/fendo.2026.1802045. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazarii Kobyliak, PhD principal investigator
Bogomolets National Medical University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic lysate (postbiotic and metabiotic) in people with Obesity and Obesity, Abdominal, run by Bogomolets National Medical University at 4 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c level (time frame: at 3 month (end of treatment) and 6 month (follow-up period) compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.