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

Sponsor
Aalborg University
Study ID
NCT07373392
Status
Not Yet Recruiting

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Conditions

  • Diabete Type 1
  • Diabete Type 2
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lactobacillus plantarum ECGC 13110402 — DIETARY_SUPPLEMENT
    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.
  • Placebo — DIETARY_SUPPLEMENT
    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.

Study Details

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 Dates

First listed
Jan 28, 2026
Start date
Jan 25, 2026
Status verified
Jan 2026
Primary completion
Mar 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: LP-LDL® (Active Treatment)
    Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks
  • Placebo Comparator: Placebo
    An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks

Primary Outcome Measure

Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) [ Time Frame: Baseline, Week 6, Week 12, Week 16 ]

Central Contacts

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