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

RecruitingNAAges 18 Years - 40 YearsAllLeeds Beckett University
NCT07073781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Lab4p Probiotic Consortium
  • Placebo
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Where

1 site
Leeds Beckett University
Leeds, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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