Cognitive Deficits, MildMENTORNCT07410052
Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination
A study testing Experimental 1 and Experimental 2 in people with Cognitive Deficits, Mild, run by Center for Health Sciences, Serbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Deficits, Mild
- What is being tested?
- Experimental 1 and Experimental 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)
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.
- Conditions
- Cognitive Deficits, Mild
- Being tested
- Experimental 1, Experimental 2
- Keywords
- Bioenergetics, Sleep quality, Cognition, Oxygenation
- Medical subject headings
- Cognition Disorders, Lymphoma, Follicular, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental 1Dietary supplement
Probiotic and riboflabin
Experimental 2Dietary supplement
Microcrystaline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | 2 capsules of probiotic and riboflavin cellulose per day Receives: Dietary Supplement: Experimental 1 |
| Experimental 2 | Placebo comparator | 2 capsules of microcrystaline cellulose per day Receives: Dietary Supplement: Experimental 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: Change from baseline PSQI at 12 weeks
Brain oxygen saturation
Concentration of hemoglobin index in prefrontal brain
Measured: Change from baseline hemoglobin index at 12 weeks
Grip strength
Muscular strength generated by one's forearm muscles
Measured: Change from baseline grip strength at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion15 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Deficits, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Health Sciences, Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikola Todorovic, PhD, Principal investigator, Center for Mitochondrial Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410052
- Sponsor's protocol ID
- 11-385-28-01
- Acronym
- MENTOR
- Status last verified
- Feb 2026
- First submitted
- 7 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in nutritional science. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)
- ClinicalTrials.gov ID
- NCT07410052
- Acronym / sponsor ID
- MENTOR / 11-385-28-01
- Conditions
- Cognitive Deficits, Mild
- Keywords
- Bioenergetics, Sleep quality, Cognition, Oxygenation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Center for Health Sciences, SerbiaUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 15 Aug 2027 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Dietary Supplement: Experimental 12 capsules of probiotic and riboflavin cellulose per day |
| Experimental 2 | Placebo comparator | Dietary Supplement: Experimental 22 capsules of microcrystaline cellulose per day |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental 1Probiotic and riboflabin | Dietary supplement | Experimental 1 |
| Experimental 2Microcrystaline cellulose | Dietary supplement | Experimental 2 |
Primary outcome
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.
4 secondary outcomes
Mini-Mental State Examination Score
Time frame: Change from baseline Mini-Mental State Examination Score at 12 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline PSQI at 12 weeks
Brain oxygen saturation
Time frame: Change from baseline hemoglobin index at 12 weeks
Grip strength
Time frame: Change from baseline grip strength at 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in nutritional science. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikola Todorovic, PhD principal investigator
Center for Mitochondrial Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Experimental 1 and Experimental 2 in people with Cognitive Deficits, Mild, run by Center for Health Sciences, Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergej Ostojic, MD, PhD (+381112643242, sergej.ostojic@chess.edu.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assesment scores (time frame: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.