A Double-blind Placebo-controlled Exploratory Trial to Assess the Impact of Daily Lab4P Probiotic Supplementation on Cognitive Performance and Metabolic Regulation in Overweight Young Adults With Impaired Glucose Regulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Verbal Memory Performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Group receiving the Lab4P probiotic capsules
Experimental group will consume oral dose of 50 billion Colony forming Units (CFU) once daily till delivery.
干预措施: Lab4p Probiotic Consortium (Dietary Supplement)
Group receiving the identical, non-active placebo
Microcrystalline cellulose/d each, up till delivery
干预措施: Placebo (Other)
结局指标
主要结局
Verbal Memory Performance
时间窗: Baseline to Week 12 (end of treatment).
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.
次要结局
- Daytime dysfunction(Baseline to Week 12 (end of treatment).)
- Circulating Markers of Platelet Activity(Baseline, Week 6, and Week 12.)
- 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).)
- Processing speed, Psychomotor Response, and Attention(Baseline to Week 12 (end of treatment).)
- Cerebrovascular Reactivity (CVR)(Baseline to Week 12 (end of treatment).)
- Flow-Mediated Dilation (FMD)(Baseline to Week 12 (end of treatment).)
- Global Sleep Quality(Baseline to Week 12 (end of treatment).)
- Sleep Disturbances(Baseline to Week 12 (end of treatment).)
- Sleep Latency(Baseline to Week 12 (end of treatment).)
- Sleep Duration(Baseline to Week 12 (end of treatment).)
- Sleep Efficiency(Baseline to Week 12 (end of treatment).)
- Sleep Medication Use(Baseline to Week 12 (end of treatment).)
- Total Cholesterol(Baseline to Week 12 (end of treatment).)
- Glycated Haemoglobin (HbA1C)(Baseline to Week 12 (end of treatment).)
- Fasting Blood Glucose(Baseline to Week 12 (end of treatment).)
- Glucose Tolerance (AUC)(Baseline to Week 12 (end of treatment).)
- Systolic blood pressure(Baseline to Week 12 (end of treatment).)
- Diastolic blood pressure(Baseline to Week 12 (end of treatment).)
- Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to Week 12 (end of treatment).)
- High-Density Lipoprotein Cholesterol (HDL-C)(Baseline to Week 12 (end of treatment).)
- Triglycerides(Baseline to Week 12 (end of treatment).)
- Body Mass Index (BMI)(Baseline to Week 12 (end of treatment).)
- Waist-to-Hip Ratio(Baseline to Week 12 (end of treatment).)
- Total Lean Mass(Baseline to Week 12 (end of treatment).)
- Total Fat Mass(Baseline to Week 12 (end of treatment).)
- Percent Body Fat(Baseline to Week 12 (end of treatment).)
- Interleukin-6 (IL-6)(Baseline to Week 12 (end of treatment).)
- Tumor Necrosis Factor-Alpha (TNF-α)(Baseline to Week 12 (end of treatment).)
- Gut Microbiota Diversity(Baseline to Week 12 (end of treatment).)
- Gut Microbiota Community Dispersion(Baseline to Week 12 (end of treatment).)
- Relative Abundance of Microbial Taxa(Baseline to Week 12 (end of treatment).)
- Adherence Rate(Baseline to Week 12 (end of treatment).)
- Physical Discomfort Symptoms(Baseline to Week 12 (end of treatment).)
研究者
Lewis Hepburn
Principal Investigator
Leeds Beckett University