Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorCenter for Health Sciences, Serbia

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Experimental 1

    Dietary supplement

    Probiotic and riboflabin

  • Experimental 2

    Dietary supplement

    Microcrystaline cellulose

Treatment groups

28 Participants
are divided into 2 treatment groups
Group A: Experimental 1Experimental treatment 1 intervention
Group B: Experimental 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Brain oxygen saturation

Concentration of hemoglobin index in prefrontal brain

Time frame
Change from baseline hemoglobin index at 12 weeks
4

Grip strength

Muscular strength generated by one's forearm muscles

Time frame
Change from baseline grip strength at 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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