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NCT Number: NCT07410052

Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination

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.

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Key information

Conditions

Cognitive Deficits, Mild Cognition Disorders Dyssomnias Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurocognitive Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental 1

Dietary Supplement

Probiotic and riboflabin

Experimental 2

Dietary Supplement

Microcrystaline cellulose

Primary outcomes

  1. Montreal Cognitive Assesment scores

    Time frame: 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.

Secondary outcomes

  1. Mini-Mental State Examination Score

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

    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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Change from baseline PSQI at 12 weeks

    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.

  3. Brain oxygen saturation

    Time frame: Change from baseline hemoglobin index at 12 weeks

    Concentration of hemoglobin index in prefrontal brain

  4. Grip strength

    Time frame: Change from baseline grip strength at 12 weeks

    Muscular strength generated by one's forearm muscles

Study contacts

Contact information is provided by the study sponsor or research team.

Sergej Ostojic, MD, PhD

CONTACT

[email protected]

+381112643242

Sponsors and collaborators

Lead sponsor

Center for Health Sciences, Serbia

Other

Registry information

Official study title

Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)

Acronym: MENTOR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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