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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
研究组 & 干预措施
LP-LDL® (Active Treatment)
Product: LP-LDL® (Lactobacillus plantarum ECGC 13110402) Dose: ≥4×10⁹ CFU, one capsule daily Duration: 12 weeks
干预措施: Lactobacillus plantarum ECGC 13110402 (Dietary Supplement)
Placebo
An identical capsule without an active bacterial strain Dose: one capsule daily Duration: 12 weeks
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in lipid profile (total cholesterol, LDL, HDL, triglycerides)
时间窗: Baseline, Week 6, Week 12, Week 16
次要结局
- 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)
- Cognitive function (Addenbrooke's Cognitive Examination-III (ACE-III))(Baseline, Week 6, Week 12, Week 16)
- CRP(Baseline, Week 6, Week 12, Week 16)
- IL-6(Baseline, Week 6, Week 12, Week 16)
研究者
Hiva Alipour
Associate Professor, Department of Health Science and Technology
Aalborg University