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

Официальное название

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)

Обзор

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

• Fasting blood glucose [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• HbA1c [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• Apolipoprotein A-I and B levels [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• Blood pressure [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• Liver enzymes (ALT, AST, ALP) [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III)) [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• CRP [Срок оценки: Baseline, Week 6, Week 12, Week 16]
• IL-6 [Срок оценки: Baseline, Week 6, Week 12, Week 16]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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%

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 2 центра

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

Публикации

• 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

Идентификаторы

NCT: NCT07373392 · N-20250029

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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