Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus
Key facts
- Where
- Gistrup, DenmarkSee the 2 sites
Where in Denmark
- Department of Health Science and Technology, Aalborg UniversityGistrup, DenmarkNo longer taking part
- Steno Diabetes Center NordjyllandGistrup, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University
- Trial code
- NCT07373392
- Record updated
- 29 January 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: Significant liver, kidney, thyroid disease; GI surgery or chronic GI disease (IBD, IBS, Crohn's disease); Severe dyslipidemia (>500 mg/dL triglycerides); Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications); Antibiotic use in the past 3 months; Pregnancy or breastfeeding; Participation in another trial within 3 months; Capsule intake <80%.