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NCT Number: NCT07373392

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

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.

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Key information

Conditions

Diabete Type 1 Autoimmune Diseases Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hypercholesterolemia Hyperinsulinism Hyperlipidemias Immune System Diseases Insulin Resistance Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases PreDiabetes Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Health Science and Technology, Aalborg University, Gistrup, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

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.

Other names: LP-LDL

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.

Primary outcomes

  1. Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)

    Time frame: Baseline, Week 6, Week 12, Week 16

Secondary outcomes

  1. Fasting blood glucose

    Time frame: Baseline, Week 6, Week 12, Week 16

  2. HbA1c

    Time frame: Baseline, Week 6, Week 12, Week 16

  3. Apolipoprotein A-I and B levels

    Time frame: Baseline, Week 6, Week 12, Week 16

  4. Blood pressure

    Time frame: Baseline, Week 6, Week 12, Week 16

  5. Liver enzymes (ALT, AST, ALP)

    Time frame: Baseline, Week 6, Week 12, Week 16

  6. Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III))

    Time frame: Baseline, Week 6, Week 12, Week 16

  7. CRP

    Time frame: Baseline, Week 6, Week 12, Week 16

  8. IL-6

    Time frame: Baseline, Week 6, Week 12, Week 16

Other outcomes

  1. Bile acid metabolites (LC-MS/GC-MS)

    Time frame: Baseline, Week 6, Week 12, Week 16

  2. Fecal microbiome composition (16S rRNA)

    Time frame: Baseline, Week 6, Week 12, Week 16

  3. Fecal fat levels

    Time frame: Baseline, Week 6, Week 12, Week 16

  4. Fecal bile salt levels

    Time frame: Baseline, Week 6, Week 12, Week 16

  5. Serum insulin/C-peptide

    Time frame: Baseline, Week 6, Week 12, Week 16

Study contacts

Contact information is provided by the study sponsor or research team.

Hiva Alipour, DVM, PhD

CONTACT

[email protected]

+45 99403807

Peter Vestergaard (PI), Chair Professor, Dr Med, PhD

CONTACT

[email protected]

+45 97663673

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • ProBiotix Health Plc.
  • Steno Diabetes Center Nordjylland

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 28, 2026
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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