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

Last updated: September 1, 2025
Sponsor: Leeds Beckett University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hormone Deficiencies

Diabetes (Pediatric)

Dementia

Treatment

Lab4p Probiotic Consortium

Placebo

Clinical Study ID

NCT07073781
LBU-Lab4P-ProCogTrial-2025
i-NutriLife Hub PoC_R3_012
  • Ages 18-35
  • All Genders

Study Summary

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 35 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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Aged 18-35 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 tolerancetesting

Exclusion

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 infarctionwithin 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

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Lab4p Probiotic Consortium
Phase:
Study Start date:
August 15, 2025
Estimated Completion Date:
August 20, 2026

Study Description

Global rates of Overweight and obesity are rising at unprecedented levels, contributing to increased metabolic disturbances such as impaired glucose metabolism. Disruptions in glucose regulation are both characteristic of and contributory to the pathogenesis of metabolic disorders, including type 2 diabetes (T2D). Clinical perturbations in glucose homeostasis are strongly associated with cognitive impairments, and an increased risk of neurodegenerative diseases. Increasing evidence suggests that even slightly impaired glucose metabolism (IGM) may contribute to cognitive decline.

Emerging evidence shows that cognitive impairments, including memory, executive function, and visuomotor deficits, can be observed in young adults with impaired glucose metabolism, alongside early markers of structural and functional brain changes. Neuroimaging studies have revealed reduced white matter integrity and decreased cerebral glucose metabolism in prediabetic individuals aged 22-35, particularly in brain regions associated with attention, self-regulation, and working memory.

These neurocognitive effects appear to be driven by early neurovascular unit (NVU) dysfunction, involving elevated blood glucose, insulin resistance (IR), endothelial damage, and inflammation. Exaggerated glucose excursions promote oxidative stress and impair endothelial function at the blood brain barrier, disrupting cerebral blood flow (CBF), glucose transport and metabolic homeostasis. Functional uncoupling between CBF and regional cerebral glucose metabolism has been directly observed in young adults with IR.

Together, these findings suggest that NVU dysfunction may underlie early cognitive decline in young adults with IGM, and that this population represents a critical target for early, non-pharmacological intervention. Probiotic formulations, including the probiotic consortium Lab4P, have shown promise in improving metabolic markers and reducing inflammation, with preclinical data suggesting potential cognitive and neuroprotective benefits. However, its procognitive effects in humans remain unexplored.

This trial will evaluate whether Lab4P supplementation can enhance cognitive performance, and cardiometabolic regulation in overweight young adults with IGM. By targeting a modifiable risk state early in life, the study aims to determine whether probiotic supplementation can serve as a viable strategy to mitigate long term neurocognitive and metabolic decline.

Connect with a study center

  • Leeds Beckett University

    Leeds, Greater Manchester LS1 3HE
    United Kingdom

    Site Not Available

  • Leeds Beckett University

    Leeds 2644688, Greater Manchester LS1 3HE
    United Kingdom

    Active - Recruiting

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