Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 2:04 AM
Study NCT ID:
NCT07373392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-21', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bile acid metabolites (LC-MS/GC-MS)', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Fecal microbiome composition (16S rRNA)', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Fecal fat levels', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Fecal bile salt levels', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Serum insulin/C-peptide', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}], 'primaryOutcomes': [{'measure': 'Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}], 'secondaryOutcomes': [{'measure': 'Fasting blood glucose', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'HbA1c', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Apolipoprotein A-I and B levels', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'Liver enzymes (ALT, AST, ALP)', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': "Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III))", 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'CRP', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}, {'measure': 'IL-6', 'timeFrame': 'Baseline, Week 6, Week 12, Week 16'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Diabete Type 1', 'Diabete Type 2', 'Prediabetes']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Shen, X., Ma, C., Yang, Y., Liu, X., Wang, B., Wang, Y., Zhang, G., Bian, X., & Zhang, N. (2024). The Role and Mechanism of Probiotics Supplementation in Blood Glucose Regulation: A Review. https://doi.org/10.3390/foods13172719'}, {'type': 'BACKGROUND', 'citation': '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. (2013). The gut microbiota suppresses insulin-mediated fat accumulation via the short-chain fatty acid receptor GPR43. Nature Communications, 4. https://doi.org/10.1038/NCOMMS2852,'}, {'type': 'BACKGROUND', 'citation': 'Dedrick, S., Sundaresh, B., Huang, Q., Brady, C., Yoo, T., Cronin, C., Rudnicki, C., Flood, M., Momeni, B., Ludvigsson, J., & Altindis, E. (2020). The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Frontiers in Endocrinology, 11, 513621. https://doi.org/10.3389/FENDO.2020.00078/XML/NLM'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'Morshedi, M., Saghafi-Asl, M., & Hosseinifard, E. S. (2020). The potential therapeutic effects of the gut microbiome manipulation by synbiotic containing-Lactobacillus plantarum on neuropsychological performance of diabetic rats. Journal of Translational Medicine, 18(1). https://doi.org/10.1186/S12967-019-02169-Y,'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': 'Costabile, A., Buttarazzi, I., Kolida, S., Quercia, S., Baldini, J., Swann, J. R., Brigidi, P., & Gibson, G. R. (2017). An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. https://doi.org/10.1371/journal.pone.0187964'}]}, 'descriptionModule': {'briefSummary': '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.\n\nA total of 210 participants will be enrolled across three parallel sub-studies:\n\n* Type 1 diabetes (n = 76)\n* Type 2 diabetes (n = 54)\n* Prediabetes (n = 80)\n\nParticipants 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).\n\nExploratory analyses include bile acid metabolism, microbiome profiling (16S rRNA), and gene expression of cholesterol transporters ABCG5/ABCG8.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Prediabetes (FPG 100-125 mg/dL or HbA1c 42-47 mmol/mol), or Type 1 or Type 2 diabetes\n* Elevated cholesterol or triglycerides (TC ≥200 mg/dL, LDL 130-189 mg/dL, or TG \\>150 mg/dL)\n* Either no lipid-lowering medication or stable dose for ≥4 weeks\n* Able to swallow capsules and understand Danish\n* Willing to maintain lifestyle habits and provide stool and blood samples\n\nExclusion Criteria:\n\n* Antibiotic use in the past 3 months\n* Severe dyslipidemia (\\>500 mg/dL triglycerides)\n* Significant liver, kidney, thyroid disease\n* Pregnancy or breastfeeding\n* GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)\n* Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications)\n* Participation in another trial within 3 months\n* Capsule intake \\<80%"}, 'identificationModule': {'nctId': 'NCT07373392', 'briefTitle': 'Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'N-20250029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LP-LDL® (Active Treatment)', 'description': 'Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks', 'interventionNames': ['Dietary Supplement: Lactobacillus plantarum ECGC 13110402']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus plantarum ECGC 13110402', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['LP-LDL'], 'description': '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.', 'armGroupLabels': ['LP-LDL® (Active Treatment)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9260', 'city': 'Gistrup', 'country': 'Denmark', 'facility': 'Department of Health Science and Technology, Aalborg University', 'geoPoint': {'lat': 56.9943, 'lon': 9.99085}}, {'zip': '9260', 'city': 'Gistrup', 'country': 'Denmark', 'contacts': [{'name': 'Peter Vestergaard, MD, PhD', 'role': 'CONTACT', 'email': 'p.vestergaard@rn.dk', 'phone': '+45 97663673'}], 'facility': 'Steno Diabetes Center Nordjylland', 'geoPoint': {'lat': 56.9943, 'lon': 9.99085}}], 'centralContacts': [{'name': 'Peter Vestergaard (PI), Chair Professor, Dr Med, PhD', 'role': 'CONTACT', 'email': 'p.vestergaard@rn.dk', 'phone': '+45 97663673'}, {'name': 'Hiva Alipour, DVM, PhD', 'role': 'CONTACT', 'email': 'hiva@hst.aau.dk', 'phone': '+45 99403807'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Steno Diabetes Center Nordjylland', 'class': 'OTHER'}, {'name': 'ProBiotix Health Plc.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Health Science and Technology', 'investigatorFullName': 'Hiva Alipour', 'investigatorAffiliation': 'Aalborg University'}}}}