Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Montreal Cognitive Assesment scores
研究概览
简要总结
This randomized, double-blind, placebo-controlled trial will evaluate whether 12 weeks of supplementation with the probiotic Lactobacillus rhamnosus GG combined with colon-delivered riboflavin will improve cognitive performance and brain physiology in older adults with memory complaints. The study will assess changes in cognitive outcomes together with neurophysiological markers to explore potential gut-brain axis mechanisms. Through its rigorous design, the trial will aim to determine whether targeted modulation of the intestinal environment can support brain function and cognitive health in aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 65 years
- •MoCA scores 18-25 points
- •BMI of 20.0 - 29.9 kg/m2 at screening
- •Stable body weight (≤ 5% change) over the past 3-months
- •Willing to avoid consuming gut microbiome-modulating dietary supplements within 4 weeks prior to the baseline visit
- •Subjects will abstain from vitamin B2-rich food intake as per pre-defined list
- •Maintain current level of physical activity
- •Be willing and able to comply with trial protocol
排除标准
- •Severe chronic disease and acute injuries
- •History of dietary supplement use four weeks before enrolment
- •Organic gastrointestinal (GI) disorders
- •Bowel surgery or short bowel syndrome
- •Gut-altering medications two months before enrolment
- •Is currently using systemic steroids, proton pump inhibitors, H2 blocker, antacid
- •History of drug and/or alcohol abuse at the time of enrolment
- •Smoker or vaper
- •Has made any major dietary changes in the past 3 months prior to baseline
- •Has a currently active eating disorder
- •Has food allergies or other issues with foods
研究组 & 干预措施
Experimental 1
2 capsules of probiotic and riboflavin cellulose per day
干预措施: Experimental 1 (Dietary Supplement)
Experimental 2
2 capsules of microcrystaline cellulose per day
干预措施: Experimental 2 (Dietary Supplement)
结局指标
主要结局
Montreal Cognitive Assesment scores
时间窗: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks
The Montreal Cognitive Assessment (MoCA) score is a brief, 30-point screening measure of global cognitive function. It assesses multiple domains, including memory, attention, executive function, language, visuospatial abilities, and orientation. Higher scores indicate better cognitive performance, with a score of 26 or above generally considered within the normal range, while lower scores suggest varying degrees of cognitive impairment.
次要结局
- Mini-Mental State Examination Score(Change from baseline Mini-Mental State Examination Score at 12 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(Change from baseline PSQI at 12 weeks)
- Brain oxygen saturation(Change from baseline hemoglobin index at 12 weeks)
- Grip strength(Change from baseline grip strength at 12 weeks)