Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07073781

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 40 Years

SexAll

Healthy volunteersNot accepted

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

Full registry 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

Treatments and study arms

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.

Primary outcomes

Verbal Memory PerformanceBaseline to Week 12 (end of treatment).

Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Verbal Recognition Memory task (VRM) a computerized word list recall task, which measures accuracy in recalling previously presented verbal stimuli to evaluate verbal memory function.

Study locations

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Leeds Beckett University🇬🇧 Leeds, Greater Manchester, United Kingdom

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Lewis F HepburnContact

Email · Call +447541333140

Lewis F HepburnPrincipal Investigator