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

Aalborg University

Status: Not yet enrolling

Conditions: Prediabetes; Diabete Type 1; Diabete Type 2

Treatments: Dietary Supplement: Lactobacillus plantarum ECGC 13110402; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07373392

N-20250029

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

210 participants in 2 patient groups, including a placebo group

LP-LDL® (Active Treatment)

Active Comparator group

Description:

Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks

Treatment:

Dietary Supplement: Lactobacillus plantarum ECGC 13110402

Placebo

Placebo Comparator group

Description:

An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks

Treatment:

Dietary Supplement: Placebo