Diabete Type 1, Diabete Type 2, Prediabetes
Conditions
Keywords
Prediabetes, Type 1 Diabetes, Type 2 Diabetes, Dyslipidemia, Hypercholesterolemia, Metabolic dysfunction, Insulin resistance, Probiotics, LP-LDL, Lactobacillus plantarum, Lactobacillus plantarum ECGC 13110402, Dietary supplement, Microbiome modulation, LDL cholesterol, Cardiometabolic health
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus 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_SUPPLEMENTPlacebo
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.
Sponsors
Aalborg University
Steno Diabetes Center Nordjylland
ProBiotix Health Plc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lipid profile (total cholesterol, LDL, HDL, triglycerides) | Baseline, Week 6, Week 12, Week 16 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Contacts
CONTACTPeter Vestergaard (PI), Chair Professor, Dr Med, PhD
CONTACTHiva Alipour, DVM, PhD
Outcome results
None listed