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Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation

Sponsor: Leeds Beckett University • ClinicalTrials.gov ID: NCT07073781

Registry updated: 2026-09-17

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Description

This 12-week, double-blind, placebo-controlled trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight adults aged 18 to 40 with impaired glucose tolerance, a preclinical condition where blood glucose regulation is mildly disrupted. Seventy participants will be randomly assigned to receive either Lab4P or a placebo. The study will assess changes in memory, executive function, and processing speed, along with blood glucose control, cardiovascular function, cholesterol levels, body composition, and markers of inflammation. The study will also analyse changes in the gut microbiome and evaluate the safety and tolerability of the probiotic.

Interventions

Lab4p Probiotic Consortium (Dietary supplement)
The investigational product in this study is Lab4P, a patented multi-strain probiotic consortium formulated as a food supplement and supplied in capsule form. Each daily dose contains a total of 5 × 10¹⁰ CFU of live bacteria, comprising five strains: Lactobacillus acidophilus CUL60 and CUL21, Lactobacillus plantarum CUL66, Bifidobacterium bifidum CUL20, and Bifidobacterium animalis subsp. lactis CUL34. In addition to probiotics, each capsule also contains three micronutrients at 100-200% of the recommended daily intake: Vitamin D (10 µg; 200%), Vitamin C (80 mg; 100%), and Zinc (10 mg; 100%). Lab4P is a marketed, human-approved product manufactured by Cultech Ltd. (Port Talbot, UK) and is classified as a food supplement, available for purchase without prescription. Both the active product and placebo will be identically packaged to maintain blinding.
Placebo (Other)
Placebo capsules are composed of microcrystalline cellulose, and are identical in appearance to the test product.

Eligibility criteria

Inclusion Criteria * Aged 18-40 years * Body Mass Index (BMI) between 25.0 and 29.9 kg/m² (classified as overweight) * In good general health (self-reported) * Normal self-reported sleep patterns, with no history of diagnosed sleep disorders * Willing and able to provide informed consent * Able to comply with study procedures, including fasting and oral glucose tolerance testing Exclusion Criteria: * Diagnosed diabetes (any type). * Diagnosed sleep disorders. * Fasting glucose \>6.9 mmol/L during screening. * History of bariatric surgery (e.g., gastric bypass, sleeve gastrectomy). * Major surgery, significant illness, trauma, infection, or myocardial infarction within the past 6 weeks. * Current use of medications affecting glucose metabolism or probiotics * Pregnancy or actively trying to conceive * Night shift work within the past month

Conditions

Impaired Glucose Regulation Impaired Glucose Tolerance (Prediabetes) Prediabetes (Insulin Resistance, Impaired Glucose Tolerance) Overweight (BMI > 25) Cognitive Dysfunction Neurovascular Coupling Mechanism and Cognitive Function

Locations

Leeds Beckett University — Leeds, Greater Manchester, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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