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

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 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.

Conditions

• Impaired Glucose Regulation
• Impaired Glucose Tolerance (Prediabetes)
• Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)
• Overweight (BMI > 25)
• Cognitive Dysfunction
• Neurovascular Coupling Mechanism and Cognitive Function

Interventions

DIETARY_SUPPLEMENT

Lab4p Probiotic Consortium

The investigational product in this study is Lab4P, a patented multi-strain probiotic consortium formulated as a food supplement and supplied in capsule form. Each daily dose contains a total of 5 × 10¹⁰ CFU of live bacteria, comprising five strains: Lactobacillus acidophilus CUL60 and CUL21, Lactobacillus plantarum CUL66, Bifidobacterium bifidum CUL20, and Bifidobacterium animalis subsp. lactis CUL34. In addition to probiotics, each capsule also contains three micronutrients at 100-200% of the recommended daily intake: Vitamin D (10 µg; 200%), Vitamin C (80 mg; 100%), and Zinc (10 mg; 100%). Lab4P is a marketed, human-approved product manufactured by Cultech Ltd. (Port Talbot, UK) and is classified as a food supplement, available for purchase without prescription. Both the active product and placebo will be identically packaged to maintain blinding.

OTHER

Placebo

Placebo capsules are composed of microcrystalline cellulose, and are identical in appearance to the test product.

Sponsors & Collaborators

• Cultech Ltd, Port Talbot, UK

  collaborator UNKNOWN

• Leeds Beckett University

  lead OTHER

Principal Investigators

• Lewis F Hepburn, Msc · Leeds Beckett University

• Lauren Owen, PhD · Leeds Beckett University

• Steve Trangmar, PhD · Leeds Beckett University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-08-15

Primary Completion

2026-06-30

Completion

2026-08-20

Countries

• United Kingdom

Study Locations