Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination

N/ANot Yet RecruitingNCT07410052

Center for Health Sciences, Serbia28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Cognitive Deficits, Mild

Interventions

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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.

Time frame: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks

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.

Time frame: Change from baseline Mini-Mental State Examination Score at 12 weeks

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.

Time frame: Change from baseline PSQI at 12 weeks

Brain oxygen saturation

Concentration of hemoglobin index in prefrontal brain

Time frame: Change from baseline hemoglobin index at 12 weeks

Grip strength

Muscular strength generated by one's forearm muscles

Time frame: Change from baseline grip strength at 12 weeks