About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Experimental 1
Dietary supplementProbiotic and riboflabin
Experimental 2
Dietary supplementMicrocrystaline cellulose
Treatment groups
Trial outcomes
Primary outcomes
Montreal Cognitive Assesment scores
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.
Secondary outcomes
Mini-Mental State Examination Score
The Mini-Mental State Examination score quantifies global cognitive function by assessing orientation, memory, attention, language, and visuospatial abilities, offering a validated measure for detecting cognitive decline in older adults.
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-report tool used to assess sleep quality and disturbances. It consists of 19 items covering seven components: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, daytime dysfunction, and use of sleep medications. Each component is scored from 0 to 3, with higher scores indicating worse sleep quality. The total score ranges from 0 to 21, where a score of 5 or higher suggests poor sleep quality. The PSQI is widely used in clinical and research settings to evaluate sleep health.
Brain oxygen saturation
Concentration of hemoglobin index in prefrontal brain
Grip strength
Muscular strength generated by one's forearm muscles
Locations
Sponsors and contacts
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