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Not yet recruiting NCT07373392

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

No phase Interventional Diabete Type 1 Diabete Type 2 Prediabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactobacillus plantarum ECGC 13110402, Placebo.
Who it may be relevant to
Registry conditions: Diabete Type 1, Diabete Type 2, Prediabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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)

Overview

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.

Interventions

  • Dietary supplement Lactobacillus plantarum ECGC 13110402
    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.
  • Dietary supplement Placebo
    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 outcome measures

  • Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) [Time frame: Baseline, Week 6, Week 12, Week 16]
Secondary outcome measures (8)
  • Fasting blood glucose [Time frame: Baseline, Week 6, Week 12, Week 16]
  • HbA1c [Time frame: Baseline, Week 6, Week 12, Week 16]
  • Apolipoprotein A-I and B levels [Time frame: Baseline, Week 6, Week 12, Week 16]
  • Blood pressure [Time frame: Baseline, Week 6, Week 12, Week 16]
  • Liver enzymes (ALT, AST, ALP) [Time frame: Baseline, Week 6, Week 12, Week 16]
  • Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III)) [Time frame: Baseline, Week 6, Week 12, Week 16]
  • CRP [Time frame: Baseline, Week 6, Week 12, Week 16]
  • IL-6 [Time frame: Baseline, Week 6, Week 12, Week 16]

Eligibility criteria

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%

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 2 centers
  • Department of Health Science and Technology, Aalborg University — Gistrup
  • Steno Diabetes Center Nordjylland — Gistrup

Publications

  • Shen X, Ma C, Yang Y, Liu X, Wang B, Wang Y, Zhang G, Bian X, Zhang N. The Role and Mechanism of Probiotics Supplementation in Blood Glucose Regulation: A Review. Foods. 2024 Aug 27;13(17):2719. doi: 10.3390/foods13172719. PMID 39272484
  • 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. The gut microbiota suppresses insulin-mediated fat accumulation via the short-chain fatty acid receptor GPR43. Nat Commun. 2013;4:1829. doi: 10.1038/ncomms2852. PMID 23652017
  • Dedrick S, Sundaresh B, Huang Q, Brady C, Yoo T, Cronin C, Rudnicki C, Flood M, Momeni B, Ludvigsson J, Altindis E. The Role of Gut Microbiota and Environmental Factors in Type 1 Diabetes Pathogenesis. Front Endocrinol (Lausanne). 2020 Feb 26;11:78. doi: 10.3389/fendo.2020.00078. eCollection 2020. PMID 32174888
  • 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
  • Morshedi M, Saghafi-Asl M, Hosseinifard ES. The potential therapeutic effects of the gut microbiome manipulation by synbiotic containing-Lactobacillus plantarum on neuropsychological performance of diabetic rats. J Transl Med. 2020 Jan 10;18(1):18. doi: 10.1186/s12967-019-02169-y. PMID 31924200
  • 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
  • Costabile A, Buttarazzi I, Kolida S, Quercia S, Baldini J, Swann JR, Brigidi P, Gibson GR. An in vivo assessment of the cholesterol-lowering efficacy of Lactobacillus plantarum ECGC 13110402 in normal to mildly hypercholesterolaemic adults. PLoS One. 2017 Dec 11;12(12):e0187964. doi: 10.1371/journal.pone.0187964. eCollection 2017. PMID 29228000

Identifiers

NCT: NCT07373392 · N-20250029

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗