Probiotic Impact on Cognitive Performance, and Metabolic Outcomes in Overweight Young Adults With Impaired Glucose Regulation
NCT ID: NCT07073781
Last Updated: 2025-12-10
Study Results
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Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2025-08-15
2026-08-20
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group receiving the Lab4P probiotic capsules
Experimental group will consume oral dose of 50 billion Colony forming Units (CFU) once daily till delivery.
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.
Group receiving the identical, non-active placebo
Microcrystalline cellulose/d each, up till delivery
Placebo
Placebo capsules are composed of microcrystalline cellulose, and are identical in appearance to the test product.
Interventions
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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.
Placebo
Placebo capsules are composed of microcrystalline cellulose, and are identical in appearance to the test product.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
35 Years
ALL
No
Sponsors
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Cultech Ltd, Port Talbot, UK
UNKNOWN
Leeds Beckett University
OTHER
Responsible Party
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Lewis Hepburn
Principal Investigator
Principal Investigators
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Lewis F Hepburn, Msc
Role: PRINCIPAL_INVESTIGATOR
Leeds Beckett University
Lauren Owen, PhD
Role: STUDY_CHAIR
Leeds Beckett University
Steve Trangmar, PhD
Role: STUDY_CHAIR
Leeds Beckett University
Locations
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Leeds Beckett University
Leeds, Greater Manchester, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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i-NutriLife Hub PoC_R3_012
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LBU-Lab4P-ProCogTrial-2025
Identifier Type: -
Identifier Source: org_study_id
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