NCT05801042已完成不适用
Comparing the Efficacy of Micro-encapsulated Lactocaseibacillus Rhamnosus Vs Free Probiotic in Powder to Affect Brain Connectivity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)
研究概览
简要总结
Aging is associated with changes in a wide variety of brain networks, including the default mode, saliency attention, and visual networks. Furthermore, current research suggests that a relationship exists between functional connectivity at rest and cognition. Lactocaseibacillus rhamnosus is an ideal strain for the intervention, as it has been show to affect the gut-brain axis, brain function, and behavior. Therefore, the investigators plan to assess resting state functional magnetic resonance imaging (fMRI) to compare changes in brain connectivity between the groups receiving the encapsulate and non-encapsulated Lactocaseibacillus rhamnosus supplements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent prior to any study-related procedure
- •Age 60-80 years-old
- •Normal weight at the screening defined as BMI range 18.5-31.9
- •Willing to abstain from regular consumption of probiotic supplements or food products containing probiotic bacteria (including fermented food and beverages)
- •Willing to abstain from regular consumption of supplements and medications known to alter gastrointestinal function or inflammatory status during the study
排除标准
- •Diagnosis of type 1 and/or type 2 diabetes
- •Current (or within the last 4 weeks prior to study start) use of probiotic supplementation
- •Immobile (defined as the inability to participate in all study-related procedures)
- •History of complicated gastrointestinal surgery
- •Diagnosed inflammatory bowel disease (IBD)
- •Current diagnosis of psychiatric disease/s or syndromes
- •Current diagnosis of neurodegenerative disease
- •Systemic use of antibiotics and/or steroid medication in the last 4 months prior to inclusion
- •Use of any non-steroidal anti-inflammatory drug (NSAID) more than 3 times a week for the last 2 months
- •Consumption of any NSAID within 7 days of study start
- •Any condition which could substantially interfere with intestinal barrier function (e.g. gluten sensitivity, lactose intolerance, celiac disease, irritable bowel syndrome (IBS), IBD) or in any other way with the outcome of the study, as decided by the principle investigator's discretion
- •Regular smoking, use of snuff, nicotine, cannabidiol narcotics/supplements, or e-cigarette use
- •Drinking more than 9 standard cups of alcohol per week and/or more than 3 standard cups of alcohol per occasion
- •Regular use, for more than three times a week for the last 2 months and/or 7 days prior to inclusion, of medications which according to the principal investigator can have an anti-inflammatory effect or affect in any way the intestinal barrier function or have an impact on the study analysis (such as laxatives, anti-diarrheal, anti-cholinergic, etc.)
- •After being included in the study, starting any medication or treatment that could potentially influence the study participation and/or study analysis
- •Cerebral bleeding or history of cerebral bleeding
- •Claustrophobia
- •In operated apparatus (e.g., pacemaker), as it interferes with MR imaging
- •Aneurysm clips in the head
- •Shunts in the head
- •Grenade-splinter or metal-splinter in the body (e.g., eyes)
- •Metal or electrodes in the body (e.g., temp-catheter, aorta stent, cochlear implant)
- •Comprehensive tooth-implants or prosthesis
- •Operated in the head
- •Operated in the heart
- •Swallowed a video-capsule, which may still be in the GI tract
- •Left-handed
结局指标
主要结局
Brain functional connectivity as measured by resting-state functional magnetic resonance imaging (fMRI)
时间窗: 6 weeks
corrected for baseline
次要结局
- Levels of inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in the brain using MR spectroscopy (MRS)(6 weeks)
- Cognitive function assessment using letter comparison test(6 weeks)
- Cognitive function assessment using Rey-Auditory Verbal Learning Test(6 weeks)
- Faecal samples for evaluation of gut microbiota composition via next-generation sequencing (NGS)(6 weeks)
- Cognitive function assessment using digit symbol substitution test (TMT)(6 weeks)
- Cognitive function assessment using Face-Name Paired Associate Task (FNPA)(6 weeks)
- Levels of metabolic blood markers (blood fats)(3 weeks)
- Levels of neural blood markers (brain derived neurotrophic factor (BDNF), serotonin)(3 weeks)
- Cognitive function assessment using the trail making test (TMT)(6 weeks)
- Cognitive function assessment using letter digit substitution test(6 weeks)
- Cognitive function assessment using N-back task(6 weeks)
- Levels of inflammatory markers (e.g. high sensitivity C-reactive protein (hsCRP), interleukin (IL)-6, tumor necrosis factor (TNF)-alpha)(3 weeks)
- Characterisation of lymphocyte subpopulations using flow cytometry(6 weeks)
研究者
Robert Brummer
Principal Investigator
Örebro University, Sweden
研究点 (2)
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