Diabete Type 1NCT07373392
Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus
A study testing Lactobacillus plantarum ECGC 13110402 in people with Diabete Type 1 and Diabete Type 2, run by Aalborg University at 2 sites in Denmark.
Trial summary
This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Type 1, Diabete Type 2, Prediabetes
- What is being tested?
- Lactobacillus plantarum ECGC 13110402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesDenmark
- Study dates
- 25 Jan 2026to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years
- Prediabetes (FPG 100-125 mg/dL or HbA1c 42-47 mmol/mol), or Type 1 or Type 2 diabetes
- Elevated cholesterol or triglycerides (TC ≥200 mg/dL, LDL 130-189 mg/dL, or TG >150 mg/dL)
- Either no lipid-lowering medication or stable dose for ≥4 weeks
- Able to swallow capsules and understand Danish
- Willing to maintain lifestyle habits and provide stool and blood samples
Who cannot join
- Antibiotic use in the past 3 months
- Severe dyslipidemia (>500 mg/dL triglycerides)
- Significant liver, kidney, thyroid disease
- Pregnancy or breastfeeding
- GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)
- Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications)
- Participation in another trial within 3 months
- Capsule intake <80%
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites
Department of Health Science and Technology, Aalborg University
Gistrup, 9260
Steno Diabetes Center Nordjylland
Gistrup, 9260
Peter Vestergaard, MD, PhD, +45 97663673, p.vestergaard@rn.dk
About this study
Official title: Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus (Type 1 and Type 2)
This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels.
A total of 210 participants will be enrolled across three parallel sub-studies:
Read more
- Type 1 diabetes (n = 76)
- Type 2 diabetes (n = 54)
- Prediabetes (n = 80)
Participants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat).
Exploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8.
The study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.
- Conditions
- Diabete Type 1, Diabete Type 2, Prediabetes
- Being tested
- Lactobacillus plantarum ECGC 13110402, Placebo
- Keywords
- Prediabetes, Type 1 Diabetes, Type 2 Diabetes, Dyslipidemia, Hypercholesterolemia, Metabolic dysfunction, Insulin resistance, Probiotics, LP-LDL, Lactobacillus plantarum, Lactobacillus plantarum ECGC 13110402, Dietary supplement, Microbiome modulation, LDL cholesterol, Cardiometabolic health
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus, Type 1, Dyslipidemias, Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum ECGC 13110402Dietary supplement
Also called LP-LDL
LP-LDL® (Lactobacillus plantarum ECGC 13110402) is a probiotic dietary supplement provided in a capsule containing a minimum of 4 × 10⁹ CFU of the viable bacterial strain at the time of release. Each active capsule contains 50 mg of freeze-dried Lactobacillus plantarum ECGC 13110402, blended with 165 mg of corn starch and 25 mg of microcrystalline cellulose as excipients. Participants assigned to the active arm will take one capsule orally once daily for 12 weeks.
PlaceboDietary supplement
The placebo consists of an identical capsule containing only the excipients (215 mg corn starch and 25 mg microcrystalline cellulose) without any live bacteria. Active and placebo capsules are identical in appearance, packaging, labeling, and handling to maintain blinding. All products are manufactured, blended, encapsulated, blind-labeled, and packaged under GMP conditions by ProBiotix Health.
| Study group | Role | What they receive |
|---|---|---|
| LP-LDL® (Active Treatment) | Active comparator | Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks Receives: Dietary Supplement: Lactobacillus plantarum ECGC 13110402 |
| Placebo | Placebo comparator | An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
Measured: Baseline, Week 6, Week 12, Week 16
Secondary outcomes (8)
Fasting blood glucose
Measured: Baseline, Week 6, Week 12, Week 16
HbA1c
Measured: Baseline, Week 6, Week 12, Week 16
Apolipoprotein A-I and B levels
Measured: Baseline, Week 6, Week 12, Week 16
Blood pressure
Measured: Baseline, Week 6, Week 12, Week 16
Liver enzymes (ALT, AST, ALP)
Measured: Baseline, Week 6, Week 12, Week 16
Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III))
Measured: Baseline, Week 6, Week 12, Week 16
CRP
Measured: Baseline, Week 6, Week 12, Week 16
IL-6
Measured: Baseline, Week 6, Week 12, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start25 Jan 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 1Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, ProBiotix Health Plc.
- Responsible party
- Principal investigator, Hiva Alipour, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373392
- Sponsor's protocol ID
- N-20250029
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset contains sensitive health information covered by the GDPR and cannot be made available outside the approved research team under Danish data protection regulations.
Publications
Shen X, Ma C, Yang Y, Liu X, Wang B, Wang Y, Zhang G, Bian X, Zhang N. The Role and Mechanism of Probiotics Supplementation in Blood Glucose Regulation: A Review. Foods. 2024 Aug 27;13(17):2719. doi: 10.3390/foods13172719.
PubMed 39272484Kimura I, Ozawa K, Inoue D, Imamura T, Kimura K, Maeda T, Terasawa K, Kashihara D, Hirano K, Tani T, Takahashi T, Miyauchi S, Shioi G, Inoue H, Tsujimoto G. The gut microbiota suppresses insulin-mediated fat accumulation via the short-chain fatty acid receptor GPR43. Nat Commun. 2013;4:1829. doi: 10.1038/ncomms2852.
PubMed 23652017Dedrick S, Sundaresh B, Huang Q, Brady C, Yoo T, Cronin C, Rudnicki C, Flood M, Momeni B, Ludvigsson J, Altindis E. The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Front Endocrinol (Lausanne). 2020 Feb 26;11:78. doi: 10.3389/fendo.2020.00078. eCollection 2020.
PubMed 32174888Abbasi, B., Mirlohi, M., Daniali, M., & Ghiasvand, R. (2018). Effects of probiotic soy milk on lipid panel in type 2 diabetic patients with nephropathy: A double-blind randomized clinical trial. Progress in Nutrition, 20(2-S), 70-78. https://doi.org/10.23751/PN.V20I2-S.5342
Morshedi M, Saghafi-Asl M, Hosseinifard ES. The potential therapeutic effects of the gut microbiome manipulation by synbiotic containing-Lactobacillus plantarum on neuropsychological performance of diabetic rats. J Transl Med. 2020 Jan 10;18(1):18. doi: 10.1186/s12967-019-02169-y.
PubMed 31924200Keleszade, E., Kolida, S., & Costabile, A. (2022). The cholesterol lowering efficacy of Lactobacillus plantarum ECGC 13110402 in hypercholesterolemic adults: a double-blind, randomized, placebo controlled, pilot human intervention study. Journal of Functional Foods, 89, 104939. https://doi.org/10.1016/J.JFF.2022.104939
Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.
PubMed 29228000
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus (Type 1 and Type 2)
- ClinicalTrials.gov ID
- NCT07373392
- Acronym / sponsor ID
- N-20250029
- Conditions
- Diabete Type 1, Diabete Type 2, Prediabetes
- Keywords
- Prediabetes, Type 1 Diabetes, Type 2 Diabetes, Dyslipidemia, Hypercholesterolemia, Metabolic dysfunction, Insulin resistance, Probiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, ProBiotix Health Plc.
- Study start
- 25 Jan 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 Jan 2026 (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.
This randomized, double-blind, placebo-controlled clinical trial investigates the effects of the probiotic LP-LDL® (Lactobacillus plantarum ECGC 13110402) on lipid metabolism, glycemic control, inflammatory biomarkers, and cognitive function in adults with prediabetes, type 1 diabetes, or type 2 diabetes who also exhibit elevated cholesterol or triglyceride levels.
A total of 210 participants will be enrolled across three parallel sub-studies:
- Type 1 diabetes (n = 76)
- Type 2 diabetes (n = 54)
- Prediabetes (n = 80)
Participants will be randomized 1:1 to receive LP-LDL® or matching placebo once daily for 12 weeks, followed by a 4-week washout period. Study assessments include fasting blood tests (lipids, glucose, HbA1c, liver enzymes, inflammatory markers), cognitive testing (ACE-III), blood pressure, anthropometry, and stool measurements (microbiome, bile acids, fecal fat).
Exploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8.
The study aims to determine whether LP-LDL® can improve cardiometabolic profiles and cognitive outcomes in these populations, and to clarify the mechanistic pathways underlying metabolic dysfunction, inflammation, and gut-brain communication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP-LDL® (Active Treatment) | Active comparator | Dietary Supplement: Lactobacillus plantarum ECGC 13110402Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAn identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥ 18 years
- Prediabetes (FPG 100-125 mg/dL or HbA1c 42-47 mmol/mol), or Type 1 or Type 2 diabetes
- Elevated cholesterol or triglycerides (TC ≥200 mg/dL, LDL 130-189 mg/dL, or TG >150 mg/dL)
- Either no lipid-lowering medication or stable dose for ≥4 weeks
- Able to swallow capsules and understand Danish
Key exclusion criteria (8 listed)
- Antibiotic use in the past 3 months
- Severe dyslipidemia (>500 mg/dL triglycerides)
- Significant liver, kidney, thyroid disease
- Pregnancy or breastfeeding
- GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)
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 |
|---|---|---|
| Lactobacillus plantarum ECGC 13110402Also: LP-LDLLP-LDL® (Lactobacillus plantarum ECGC 13110402) is a probiotic dietary supplement provided in a capsule containing a minimum of 4 × 10⁹ CFU of the viable bacterial strain at the time of release. Each active capsule contains 50 mg of freeze-dried Lactobacillus plantarum ECGC 13110402, blended with 165 mg of corn starch and 25 mg of microcrystalline cellulose as excipients. Participants assigned to the active arm will take one capsule orally once daily for 12 weeks. | Dietary supplement | LP-LDL® (Active Treatment) |
| PlaceboThe placebo consists of an identical capsule containing only the excipients (215 mg corn starch and 25 mg microcrystalline cellulose) without any live bacteria. Active and placebo capsules are identical in appearance, packaging, labeling, and handling to maintain blinding. All products are manufactured, blended, encapsulated, blind-labeled, and packaged under GMP conditions by ProBiotix Health. | Dietary supplement | Placebo |
Primary outcome
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
Time frame: Baseline, Week 6, Week 12, Week 16
8 secondary outcomes
Fasting blood glucose
Time frame: Baseline, Week 6, Week 12, Week 16
HbA1c
Time frame: Baseline, Week 6, Week 12, Week 16
Apolipoprotein A-I and B levels
Time frame: Baseline, Week 6, Week 12, Week 16
Blood pressure
Time frame: Baseline, Week 6, Week 12, Week 16
Liver enzymes (ALT, AST, ALP)
Time frame: Baseline, Week 6, Week 12, Week 16
Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III))
Time frame: Baseline, Week 6, Week 12, Week 16
CRP
Time frame: Baseline, Week 6, Week 12, Week 16
IL-6
Time frame: Baseline, Week 6, Week 12, Week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Background: PubMed 39272484Shen X, Ma C, Yang Y, Liu X, Wang B, Wang Y, Zhang G, Bian X, Zhang N. The Role and Mechanism of Probiotics Supplementation in Blood Glucose Regulation: A Review. Foods. 2024 Aug 27;13(17):2719. doi: 10.3390/foods13172719.
- Background: PubMed 23652017Kimura I, Ozawa K, Inoue D, Imamura T, Kimura K, Maeda T, Terasawa K, Kashihara D, Hirano K, Tani T, Takahashi T, Miyauchi S, Shioi G, Inoue H, Tsujimoto G. The gut microbiota suppresses insulin-mediated fat accumulation via the short-chain fatty acid receptor GPR43. Nat Commun. 2013;4:1829. doi: 10.1038/ncomms2852.
- Background: PubMed 32174888Dedrick S, Sundaresh B, Huang Q, Brady C, Yoo T, Cronin C, Rudnicki C, Flood M, Momeni B, Ludvigsson J, Altindis E. The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Front Endocrinol (Lausanne). 2020 Feb 26;11:78. doi: 10.3389/fendo.2020.00078. eCollection 2020.
- BackgroundAbbasi, B., Mirlohi, M., Daniali, M., & Ghiasvand, R. (2018). Effects of probiotic soy milk on lipid panel in type 2 diabetic patients with nephropathy: A double-blind randomized clinical trial. Progress in Nutrition, 20(2-S), 70-78. https://doi.org/10.23751/PN.V20I2-S.5342
- Background: PubMed 31924200Morshedi M, Saghafi-Asl M, Hosseinifard ES. The potential therapeutic effects of the gut microbiome manipulation by synbiotic containing-Lactobacillus plantarum on neuropsychological performance of diabetic rats. J Transl Med. 2020 Jan 10;18(1):18. doi: 10.1186/s12967-019-02169-y.
- BackgroundKeleszade, E., Kolida, S., & Costabile, A. (2022). The cholesterol lowering efficacy of Lactobacillus plantarum ECGC 13110402 in hypercholesterolemic adults: a double-blind, randomized, placebo controlled, pilot human intervention study. Journal of Functional Foods, 89, 104939. https://doi.org/10.1016/J.JFF.2022.104939
- Background: PubMed 29228000Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset contains sensitive health information covered by the GDPR and cannot be made available outside the approved research team under Danish data protection regulations.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus plantarum ECGC 13110402 in people with Diabete Type 1 and Diabete Type 2, run by Aalborg University at 2 sites in Denmark.
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 6 inclusion and 8 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: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Vestergaard (PI), Chair Professor, Dr Med, PhD (+45 97663673, p.vestergaard@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) (time frame: Baseline, Week 6, Week 12, Week 16). 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 NCT07373392, which also lists 7 linked publications.
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 29 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.