Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus

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:

• 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 Overview

• Status: Not yet recruiting
• Conditions: Prediabetes; Diabete Type 2; Diabete Type 1
• Intervention / Treatment: Dietary supplement: Lactobacillus plantarum ECGC 13110402; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Vestergaard (PI), Chair Professor, Dr Med, PhD; Phone Number: +45 97663673; Email: p.vestergaard@rn.dk
• Study Contact Backup: Name: Hiva Alipour, DVM, PhD; Phone Number: +45 99403807; Email: hiva@hst.aau.dk

Study Locations

• Denmark
  • Gistrup, Denmark, 9260
    • Steno Diabetes Center Nordjylland
    • Contact: Peter Vestergaard, MD, PhD; Phone Number: +45 97663673; Email: p.vestergaard@rn.dk
  • Gistrup, Denmark, 9260
    • Department of Health Science and Technology, Aalborg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LP-LDL® (Active Treatment); Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks	Dietary supplement: Lactobacillus plantarum ECGC 13110402; 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.; Other Names: LP-LDL
Placebo Comparator: Placebo; An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks	Dietary supplement: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)	Baseline, Week 6, Week 12, Week 16

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
Serum insulin/C-peptide	Baseline, Week 6, Week 12, Week 16
Fecal fat levels	Baseline, Week 6, Week 12, Week 16
Fecal bile salt levels	Baseline, Week 6, Week 12, Week 16

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Steno Diabetes Center Nordjylland; ProBiotix Health Plc.

Publications and helpful links

General Publications

• 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
• 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,
• 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
• 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
• 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,
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): January 29, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Insulin resistance; Dyslipidemia; Prediabetes; Dietary supplement; Probiotics; Type 2 Diabetes; Hypercholesterolemia; Type 1 Diabetes; LDL cholesterol; Lactobacillus plantarum; Metabolic dysfunction; Cardiometabolic health; LP-LDL; Lactobacillus plantarum ECGC 13110402; Microbiome modulation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Hyperlipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Hypercholesterolemia; Diabetes Mellitus, Type 1; Insulin Resistance; Dyslipidemias; Prediabetic State
• Other Study ID Numbers: N-20250029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No