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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Diabete Type 1, Diabete Type 2, Prediabetes

In brief

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.

Key facts

Study ID

NCT07373392

Run by

Aalborg University

People needed

210

Starts

2026-01-25

Expected to finish

2028-09-01

Last updated by the study team

2026-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Department of Health Science and Technology, Aalborg University — Gistrup, Denmark
• Steno Diabetes Center Nordjylland — Gistrup, Denmark

Full record on ClinicalTrials.gov

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