A probiotic supplement for cholesterol and blood sugar in prediabetes and diabetes
Tests a probiotic supplement against placebo in adults with prediabetes or diabetes.
Plain-language title generated from the registry record
Registry title: Effects of LP-LDL® on Lipid Metabolism, Glycemic Control, Inflammatory Markers, and Cognitive Function in Individuals With Prediabetes and Diabetes Mellitus
Key facts
- Where
- Gistrup, DenmarkSee the 2 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with prediabetes, type 1 diabetes or type 2 diabetes who also have high cholesterol or high triglycerides. It tests a probiotic, LP-LDL®, against a placebo.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Prediabetes (fasting glucose 100-125 mg/dL (5.6–6.9 mmol/L) or HbA1c 42-47 mmol/mol (6–6.5%)), or type 1 or type 2 diabetes. Also high cholesterol or triglycerides (total cholesterol ≥200 mg/dL (5.2 mmol/L), LDL 130-189 mg/dL (3.4–4.9 mmol/L), or triglycerides >150 mg/dL (1.7 mmol/L)).
- Earlier treatment
- No cholesterol-lowering medicine, or the same dose for at least 4 weeks. No antibiotics in the past 3 months.
Main reasons for not taking part
- Antibiotic use in the past 3 months
- Very high triglycerides (>500 mg/dL (5.6 mmol/L))
- Significant liver, kidney or thyroid disease
- Pregnancy or breastfeeding
- Stomach or bowel surgery, or long-term bowel disease (IBD, IBS, Crohn's disease)
Read by machine on 9 November 2026.
Where in Denmark
- Department of Health Science and Technology, Aalborg UniversityGistrup, DenmarkNo longer taking part
- Steno Diabetes Center NordjyllandGistrup, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aalborg University
- Trial code
- NCT07373392
- Record updated
- 29 January 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Significant liver, kidney, thyroid disease; GI surgery or chronic GI disease (IBD, IBS, Crohn's disease); Severe dyslipidemia (>500 mg/dL triglycerides); Long-term medications influencing lipid/glucose metabolism (except approved antidiabetic medications); Antibiotic use in the past 3 months; Pregnancy or breastfeeding; Participation in another trial within 3 months; Capsule intake <80%.