NCT07373392

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Jan 2026Sep 2028

First Submitted

Initial submission to the registry

January 21, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

2.1 years

First QC Date

January 21, 2026

Last Update Submit

January 27, 2026

Conditions

Diabete Type 1Diabete Type 2Prediabetes

Keywords

PrediabetesType 1 DiabetesType 2 DiabetesDyslipidemiaHypercholesterolemiaMetabolic dysfunctionInsulin resistanceProbioticsLP-LDLLactobacillus plantarumLactobacillus plantarum ECGC 13110402Dietary supplementMicrobiome modulationLDL cholesterolCardiometabolic health

Outcome Measures

Primary Outcomes (1)

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

    Baseline, Week 6, Week 12, Week 16

Secondary Outcomes (8)

  • Fasting blood glucose

    Baseline, Week 6, Week 12, Week 16

  • HbA1c

    Baseline, Week 6, Week 12, Week 16

  • Apolipoprotein A-I and B levels

    Baseline, Week 6, Week 12, Week 16

  • Blood pressure

    Baseline, Week 6, Week 12, Week 16

  • Liver enzymes (ALT, AST, ALP)

    Baseline, Week 6, Week 12, Week 16

  • +3 more secondary outcomes

Other Outcomes (5)

  • Bile acid metabolites (LC-MS/GC-MS)

    Baseline, Week 6, Week 12, Week 16

  • Fecal microbiome composition (16S rRNA)

    Baseline, Week 6, Week 12, Week 16

  • Fecal fat levels

    Baseline, Week 6, Week 12, Week 16

  • +2 more other outcomes

Study Arms (2)

LP-LDL® (Active Treatment)

ACTIVE COMPARATOR

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

Dietary Supplement: Lactobacillus plantarum ECGC 13110402

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Lactobacillus plantarum ECGC 13110402DIETARY_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.

Also known as: LP-LDL
LP-LDL® (Active Treatment)
PlaceboDIETARY_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.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Health Science and Technology, Aalborg University

Gistrup, 9260, Denmark

Location

Steno Diabetes Center Nordjylland

Gistrup, 9260, Denmark

Location

Related Publications (7)

  • Shen, X., Ma, C., Yang, Y., Liu, X., Wang, B., Wang, Y., Zhang, G., Bian, X., & Zhang, N. (2024). The Role and Mechanism of Probiotics Supplementation in Blood Glucose Regulation: A Review. https://doi.org/10.3390/foods13172719

    BACKGROUND

  • Kimura, I., Ozawa, K., Inoue, D., Imamura, T., Kimura, K., Maeda, T., Terasawa, K., Kashihara, D., Hirano, K., Tani, T., Takahashi, T., Miyauchi, S., Shioi, G., Inoue, H., & Tsujimoto, G. (2013). The gut microbiota suppresses insulin-mediated fat accumulation via the short-chain fatty acid receptor GPR43. Nature Communications, 4. https://doi.org/10.1038/NCOMMS2852,

    BACKGROUND

  • Dedrick, S., Sundaresh, B., Huang, Q., Brady, C., Yoo, T., Cronin, C., Rudnicki, C., Flood, M., Momeni, B., Ludvigsson, J., & Altindis, E. (2020). The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Frontiers in Endocrinology, 11, 513621. https://doi.org/10.3389/FENDO.2020.00078/XML/NLM

    BACKGROUND

  • Abbasi, B., Mirlohi, M., Daniali, M., & Ghiasvand, R. (2018). Effects of probiotic soy milk on lipid panel in type 2 diabetic patients with nephropathy: A double-blind randomized clinical trial. Progress in Nutrition, 20(2-S), 70-78. https://doi.org/10.23751/PN.V20I2-S.5342

    BACKGROUND

  • Morshedi, M., Saghafi-Asl, M., & Hosseinifard, E. S. (2020). The potential therapeutic effects of the gut microbiome manipulation by synbiotic containing-Lactobacillus plantarum on neuropsychological performance of diabetic rats. Journal of Translational Medicine, 18(1). https://doi.org/10.1186/S12967-019-02169-Y,

    BACKGROUND

  • Keleszade, E., Kolida, S., & Costabile, A. (2022). The cholesterol lowering efficacy of Lactobacillus plantarum ECGC 13110402 in hypercholesterolemic adults: a double-blind, randomized, placebo controlled, pilot human intervention study. Journal of Functional Foods, 89, 104939. https://doi.org/10.1016/J.JFF.2022.104939

    BACKGROUND

  • Costabile, A., Buttarazzi, I., Kolida, S., Quercia, S., Baldini, J., Swann, J. R., Brigidi, P., & Gibson, G. R. (2017). An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. https://doi.org/10.1371/journal.pone.0187964

    BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateDiabetes Mellitus, Type 1DyslipidemiasHypercholesterolemiaInsulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesLipid Metabolism DisordersHyperlipidemiasHyperinsulinism

Central Study Contacts

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

CONTACT

+45 97663673p.vestergaard@rn.dk

Hiva Alipour, DVM, PhD

CONTACT

+45 99403807hiva@hst.aau.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Health Science and Technology

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 28, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because the dataset contains sensitive health information covered by the GDPR and cannot be made available outside the approved research team under Danish data protection regulations.

Locations

DK(2)