Daily Lab4P probiotic to improve thinking and metabolic health in overweight young adults with mild glucose regulation problems.
A Double-blind Placebo-controlled Exploratory Trial to Assess the Impact of Daily Lab4P Probiotic Supplementation on Cognitive Performance and Metabolic Regulation in Overweight Young Adults With Impaired Glucose Regulation
This 12-week trial will test whether taking a daily Lab4P probiotic can improve memory, thinking speed, and blood sugar control in overweight 18–40-year-olds with mildly impaired glucose regulation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Leeds Beckett University Academic / other |
| Locations | 1 site (Leeds, Greater Manchester) |
| Trial ID | NCT07073781 on ClinicalTrials.gov |
What this trial studies
This is a 12-week, randomized, double-blind, placebo-controlled trial in which 70 overweight adults aged 18–40 with impaired glucose tolerance will take either the Lab4P probiotic or a matching placebo daily. Cognitive performance (memory, executive function, processing speed) and a range of metabolic outcomes (oral glucose tolerance, fasting glucose, lipids, body composition, cardiovascular measures, and inflammatory markers) will be measured before and after the intervention. The study will also analyze changes in the gut microbiome and monitor safety and tolerability throughout the intervention. Results will compare changes between the probiotic and placebo groups to see if the probiotic produces measurable cognitive or metabolic benefits.
Who should consider this trial
Good fit: Ideal candidates are 18–40 years old, have a BMI of 25.0–29.9 kg/m², are in generally good health, and have impaired glucose tolerance but not diagnosed diabetes.
Not a fit: People with diagnosed diabetes, BMI outside the 25.0–29.9 range, current use of glucose-altering medications or probiotics, pregnancy, recent major surgery, or recent night-shift work are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If successful, the probiotic could offer a simple, well-tolerated way to modestly improve cognitive function and metabolic markers in overweight young adults with early glucose dysregulation.
How similar studies have performed: Some smaller trials and preclinical work suggest certain probiotics can modestly improve metabolic markers and aspects of mood or cognition, but the Lab4P combination in overweight young adults with impaired glucose tolerance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Leeds, Greater Manchester
- Leeds Beckett University — Leeds, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Lewis F Hepburn, Msc — Leeds Beckett University
- Study coordinator: Lewis F Hepburn
- Email: l.hepburn3449@student.leedsbeckett.ac.uk
- Phone: +447541333140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.