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

NCT07073781 | Recruiting

• 2 other identifiers: LBU-Lab4P-ProCogTrial-2025i-NutriLife Hub PoC_R3_012
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

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

Keywords

Probiotic supplementation; Psychobiotic; Cognitive performance; Metabolic function; Impaired glucose tolerance; Gut-brain axis

Outcome Measures

Primary Outcomes (1)

• Verbal Memory Performance

  Assessed using the Cambridge Neuropsychological Test Automated Battery (CANTAB) Verbal Recognition Memory task (VRM) a computerized word list recall task, which measures accuracy in recalling previously presented verbal stimuli to evaluate verbal memory function.

  Baseline to Week 12 (end of treatment).

Secondary Outcomes (37)

• Visual Episodic Memory

  Baseline to Week 12 (end of treatment).

• Number of Participants Reporting One or More Adverse Events (AEs) or Serious Adverse Events (SAEs)

  Baseline to Week 12 (end of treatment).

• Visuospatial Working Memory

  Baseline to Week 12 (end of treatment).

• Executive function (Response Inhibition and Impulse Control)

  Baseline to Week 12 (end of treatment).

• Executive function (Cognitive Flexibility and Attentional Set-Shifting)

  Baseline to Week 12 (end of treatment).

Study Arms (2)

Group receiving the Lab4P probiotic capsules

EXPERIMENTAL

Experimental group will consume oral dose of 50 billion Colony forming Units (CFU) once daily till delivery.

Dietary Supplement: Lab4p Probiotic Consortium

Group receiving the identical, non-active placebo

PLACEBO COMPARATOR

Microcrystalline cellulose/d each, up till delivery

Other: Placebo

Interventions

Lab4p Probiotic Consortium DIETARY_SUPPLEMENT

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.

Group receiving the Lab4P probiotic capsules

Placebo OTHER

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

Group receiving the identical, non-active placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leeds Beckett University: lead
• Cultech Ltd, Port Talbot, UK: collaborator

Study Sites (1)

Leeds Beckett University

Leeds, Greater Manchester, LS1 3HE, United Kingdom

RECRUITING

Related Publications (14)

• Zilliox LA, Chadrasekaran K, Kwan JY, Russell JW. Diabetes and Cognitive Impairment. Curr Diab Rep. 2016 Sep;16(9):87. doi: 10.1007/s11892-016-0775-x.

  PMID: 27491830 BACKGROUND

• Webberley TS, Bevan RJ, Kerry-Smith J, Dally J, Michael DR, Thomas S, Rees M, Morgan JE, Marchesi JR, Good MA, Plummer SF, Wang D, Hughes TR. Assessment of Lab4P Probiotic Effects on Cognition in 3xTg-AD Alzheimer's Disease Model Mice and the SH-SY5Y Neuronal Cell Line. Int J Mol Sci. 2023 Feb 28;24(5):4683. doi: 10.3390/ijms24054683.

  PMID: 36902113 BACKGROUND

• Sadler JR, Shearrer GE, Burger KS. Alterations in ventral attention network connectivity in individuals with prediabetes. Nutr Neurosci. 2021 Feb;24(2):140-147. doi: 10.1080/1028415X.2019.1609646. Epub 2019 Apr 28.

  PMID: 31030631 BACKGROUND

• Ribeiro M, Yordanova YN, Noblet V, Herbet G, Ricard D. White matter tracts and executive functions: a review of causal and correlation evidence. Brain. 2024 Feb 1;147(2):352-371. doi: 10.1093/brain/awad308.

  PMID: 37703295 BACKGROUND

• Repple J, Karliczek G, Meinert S, Forster K, Grotegerd D, Goltermann J, Redlich R, Arolt V, Baune BT, Dannlowski U, Opel N. Variation of HbA1c affects cognition and white matter microstructure in healthy, young adults. Mol Psychiatry. 2021 Apr;26(4):1399-1408. doi: 10.1038/s41380-019-0504-3. Epub 2019 Aug 29.

  PMID: 31467393 BACKGROUND

• Nazaribadie M, Amini M, Ahmadpanah M, Asgari K, Jamlipaghale S, Nazaribadie S. Executive functions and information processing in patients with type 2 diabetes in comparison to pre-diabetic patients. J Diabetes Metab Disord. 2014 Feb 4;13(1):27. doi: 10.1186/2251-6581-13-27.

  PMID: 24495302 BACKGROUND

• Michael DR, Davies TS, Jack AA, Masetti G, Marchesi JR, Wang D, Mullish BH, Plummer SF. Daily supplementation with the Lab4P probiotic consortium induces significant weight loss in overweight adults. Sci Rep. 2021 Jan 6;11(1):5. doi: 10.1038/s41598-020-78285-3.

  PMID: 33408364 BACKGROUND

• Lamport DJ, Lawton CL, Mansfield MW, Dye L. Impairments in glucose tolerance can have a negative impact on cognitive function: a systematic research review. Neurosci Biobehav Rev. 2009 Mar;33(3):394-413. doi: 10.1016/j.neubiorev.2008.10.008. Epub 2008 Nov 5.

  PMID: 19026680 BACKGROUND

• Kullmann S, Heni M, Hallschmid M, Fritsche A, Preissl H, Haring HU. Brain Insulin Resistance at the Crossroads of Metabolic and Cognitive Disorders in Humans. Physiol Rev. 2016 Oct;96(4):1169-209. doi: 10.1152/physrev.00032.2015. Epub 2016 Aug 3.

  PMID: 27489306 BACKGROUND

• Kirvalidze M, Hodkinson A, Storman D, Fairchild TJ, Bala MM, Beridze G, Zuriaga A, Brudasca NI, Brini S. The role of glucose in cognition, risk of dementia, and related biomarkers in individuals without type 2 diabetes mellitus or the metabolic syndrome: A systematic review of observational studies. Neurosci Biobehav Rev. 2022 Apr;135:104551. doi: 10.1016/j.neubiorev.2022.104551. Epub 2022 Jan 29.

  PMID: 35104494 BACKGROUND

• Feng L, Gao L. The role of neurovascular coupling dysfunction in cognitive decline of diabetes patients. Front Neurosci. 2024 Mar 21;18:1375908. doi: 10.3389/fnins.2024.1375908. eCollection 2024.

  PMID: 38576869 BACKGROUND

• Di Pino A, Urbano F, Scicali R, Di Mauro S, Filippello A, Scamporrino A, Piro S, Purrello F, Rabuazzo AM. 1 h Postload Glycemia Is Associated with Low Endogenous Secretory Receptor for Advanced Glycation End Product Levels and Early Markers of Cardiovascular Disease. Cells. 2019 Aug 16;8(8):910. doi: 10.3390/cells8080910.

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• Deery HA, Liang E, Di Paolo R, Voigt K, Murray G, Siddiqui MN, Egan GF, Moran C, Jamadar SD. The association of regional cerebral blood flow and glucose metabolism in normative ageing and insulin resistance. Sci Rep. 2024 Jun 25;14(1):14574. doi: 10.1038/s41598-024-65396-4.

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• Deery HA, Liang E, Di Paolo R, Voigt K, Murray G, Siddiqui MN, Egan GF, Moran C, Jamadar SD. Peripheral insulin resistance attenuates cerebral glucose metabolism and impairs working memory in healthy adults. NPJ Metab Health Dis. 2024 Aug 2;2(1):17. doi: 10.1038/s44324-024-00019-0.

  PMID: 40604159 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Prediabetic State; Insulin Resistance; Overweight; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Hyperinsulinism; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lewis F Hepburn, Msc

  Leeds Beckett University

  PRINCIPAL INVESTIGATOR

• Lauren Owen, PhD

  Leeds Beckett University

  STUDY CHAIR

• Steve Trangmar, PhD

  Leeds Beckett University

  STUDY CHAIR

Central Study Contacts

Lewis F Hepburn

CONTACT

+447541333140; l.hepburn3449@student.leedsbeckett.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups (Lab4P or placebo) and will receive their assigned intervention daily for 12 weeks. There will be no crossover between groups, and outcomes will be assessed at multiple time points across the intervention period.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: IPD and supporting information will be available after publication of the primary trial results. Data will remain accessible for a minimum of 5 years following the end of the study or until the end of the institutional data retention period, whichever is longer.
• Access Criteria: Access to IPD and supporting information will be granted to qualified researchers who provide a sound scientific rationale and appropriate ethical approvals. Requests will be evaluated by the study team and data custodians at Leeds Beckett University. Sensitive data will only be shared under a data-sharing agreement and subject to participant consent and ethics approval. Access will be coordinated via the Leeds Beckett University Thesis and Research Data Repository.

Locations

GB (1)