Daily Lab4P probiotic to improve thinking and metabolic health in overweight young adults with mild glucose regulation problems.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA Written informed consent provided before any study-related procedures. Aged 18-40 years, inclusive, at the time of consent. BMI ≥25.0 kg/m². Self-reported good general health, with no chronic medical conditions requiring ongoing treatment.

Self-reported normal sleep patterns, with no history of diagnosed sleep disorders.

Willing and able to comply with study procedures, including fasting and oral glucose tolerance testing (OGTT).

Non-smoker at screening, with no regular tobacco use in the preceding six months.

English proficiency equivalent to that of a native speaker.

EXCLUSION CRITERIA Current or past diagnosis of diabetes mellitus of any type. Fasting plasma glucose ≤3.9 or ≥7.0 mmol/L at screening. Diagnosed sleep disorder. History of bariatric surgery or other gastrointestinal procedures that may affect glucose absorption or metabolism.

Major surgery, significant trauma, systemic infection, or myocardial infarction within six weeks before screening.

History of kidney disease, liver disease, low or high blood pressure, or heart disease.

History of conditions that may affect food metabolism, including food allergies or gastrointestinal diseases such as irritable bowel syndrome or peptic ulcers.

Current or recent use, within four weeks, of medications affecting glucose metabolism or agents that may alter gut microbiota composition or probiotic efficacy, as defined in Section 8.6.

History of psychiatric illness, including anxiety or depression. Current use of prescription or over-the-counter medications, excluding hormonal contraception.

Night shift work within 30 days before screening or planned during the study. Pregnancy, breastfeeding, or plans to become pregnant during the study. Known allergy or hypersensitivity to any component of the investigational product or placebo.

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.