Clinical trial · Interventional
Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination
Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cognitive Deficits, Mild | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Experimental 1 | Dietary Supplement | — | UNRESOLVED |
| Experimental 2 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental 1
- description
- 2 capsules of probiotic and riboflavin cellulose per day
- interventionNames
- Dietary Supplement: Experimental 1
- type
- PLACEBO_COMPARATOR
- label
- Experimental 2
- description
- 2 capsules of microcrystaline cellulose per day
- interventionNames
- Dietary Supplement: Experimental 2
Primary outcomes (1)
- measure
- Montreal Cognitive Assesment scores
- timeFrame
- Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available