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| Name | Class |
|---|---|
| Steno Diabetes Center Nordjylland | OTHER |
| ProBiotix Health Plc. | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LP-LDL® (Active Treatment) | Active Comparator | Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks |
|
| Placebo | Placebo Comparator | An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus plantarum ECGC 13110402 | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) | Baseline, Week 6, Week 12, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting blood glucose | Baseline, Week 6, Week 12, Week 16 | |
| HbA1c | Baseline, Week 6, Week 12, Week 16 | |
| Apolipoprotein A-I and B levels |
| Measure | Description | Time Frame |
|---|---|---|
| Bile acid metabolites (LC-MS/GC-MS) | Baseline, Week 6, Week 12, Week 16 | |
| Fecal microbiome composition (16S rRNA) | Baseline, Week 6, Week 12, Week 16 | |
| Fecal fat levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Vestergaard (PI), Chair Professor, Dr Med, PhD | Contact | +45 97663673 | p.vestergaard@rn.dk | |
| Hiva Alipour, DVM, PhD | Contact | +45 99403807 | hiva@hst.aau.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health Science and Technology, Aalborg University | Gistrup | 9260 | Denmark | |||
| Steno Diabetes Center Nordjylland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39272484 | Background | 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. | |
| 23652017 | Background | Kimura 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. |
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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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|
| Placebo | Dietary 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. |
|
| Baseline, Week 6, Week 12, Week 16 |
| Blood pressure | Baseline, Week 6, Week 12, Week 16 |
| Liver enzymes (ALT, AST, ALP) | Baseline, Week 6, Week 12, Week 16 |
| Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III)) | Baseline, Week 6, Week 12, Week 16 |
| CRP | Baseline, Week 6, Week 12, Week 16 |
| IL-6 | Baseline, Week 6, Week 12, Week 16 |
| Baseline, Week 6, Week 12, Week 16 |
| Fecal bile salt levels | Baseline, Week 6, Week 12, Week 16 |
| Serum insulin/C-peptide | Baseline, Week 6, Week 12, Week 16 |
| Gistrup |
| 9260 |
| Denmark |
|
| 32174888 | Background | Dedrick 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. |
| Background | Abbasi, 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 |
| 31924200 | Background | 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. |
| Background | Keleszade, 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 |
| 29228000 | Background | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011236 | Prediabetic State |
| D003922 | Diabetes Mellitus, Type 1 |
| D050171 | Dyslipidemias |
| D006937 | Hypercholesterolemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D052439 | Lipid Metabolism Disorders |
| D006949 | Hyperlipidemias |
| D006946 | Hyperinsulinism |
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