Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental 1, Experimental 2.
- Who it may be relevant to
- Registry conditions: Cognitive Deficits, Mild. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination (MENTOR)
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.
Interventions
- Dietary supplement Experimental 1
Probiotic and riboflabin - Dietary supplement Experimental 2
Microcrystaline cellulose
Primary outcome measures
- Montreal Cognitive Assesment scores [Time frame: Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks]
Secondary outcome measures (4)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07410052 · 11-385-28-01