NCT07373392Not yet recruiting
Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus
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)
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 25 Jan 2026
- Primary completion date
- 1 Mar 2028
- Lead sponsor
- Aalborg University
- NCT number
- NCT07373392
What you commit to
- Study type: Interventional
- Planned participants: 210
- From 25 Jan 2026 to the primary completion date, 1 Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant liver, kidney, thyroid disease
- GI surgery or chronic GI disease (IBD, IBS, Crohn's disease)
Lab values
- Severe dyslipidemia (\>500 mg/dL triglycerides)
- Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications)
Other
- Antibiotic use in the past 3 months
- Pregnancy or breastfeeding
- Participation in another trial within 3 months
- Capsule intake \<80%
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Health Science and Technology, Aalborg University Coordinator of this site? Confirm its status | Gistrup | Denmark | Unknown status |
| Steno Diabetes Center Nordjylland Coordinator of this site? Confirm its status | Gistrup | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.