NCT07073781Recruiting
Probiotics, Cognition and Metabolic Health in Young Adults With Overweight or Obesity
A Double-Blind, Placebo-Controlled Exploratory Trial Of Daily Lab4P Probiotic Supplementation For Cognitive Performance And Metabolic Regulation In Young Adults With Overweight Or Obesity
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
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 and obese adults aged 18 to 40. 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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 15 Aug 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Leeds Beckett University
- Diseases
- Obesity
- NCT number
- NCT07073781
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 15 Aug 2025 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 40 with a BMI of 25.0 kg/m² or more who say they are in good general health. It tests a daily probiotic against a placebo.
- Age
- 18 to 40 years, inclusive.
- Sex
- All sexes can join.
- Disease stage
- BMI of 25.0 kg/m² or more. Self-reported good general health, with no chronic condition that needs ongoing treatment.
- Earlier treatment
- No medicine that affects glucose metabolism or gut bacteria in the last 4 weeks. No current prescription or over-the-counter medicines, except hormonal contraception.
- Biomarker or test result
- Fasting plasma glucose must not be 3.9 mmol/L or lower, or 7.0 mmol/L or higher, at screening.
Main reasons for not taking part
- Diabetes of any type, now or in the past
- Diagnosed sleep disorder, or night shift work
- Kidney, liver or heart disease, or blood pressure that is too low or too high
- Psychiatric illness, including anxiety or depression
- Pregnancy, breastfeeding, or plans to become pregnant
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Major surgery, significant trauma, systemic infection, or myocardial infarction within six weeks before screening.
- 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.
Other illness
- 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.
- History of psychiatric illness, including anxiety or depression. Current use of prescription or over-the-counter medications, excluding hormonal contraception.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Leeds Beckett University | Leeds | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.