Microbiome-Targeted Enhancement of Neurocognition With Probiotics-Riboflavin Combination

NCT07410052 | Not Yet Recruiting

• 1 other identifier: 11-385-28-01
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Bioenergetics; Sleep quality; Cognition; Oxygenation

Outcome Measures

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.

  Change from baseline The Montreal Cognitive Assessment (MoCA) score at 12 weeks

Secondary Outcomes (4)

• Mini-Mental State Examination Score

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

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline PSQI at 12 weeks

• Brain oxygen saturation

  Change from baseline hemoglobin index at 12 weeks

• Grip strength

  Change from baseline grip strength at 12 weeks

Study Arms (2)

Experimental 1

EXPERIMENTAL

2 capsules of probiotic and riboflavin cellulose per day

Dietary Supplement: Experimental 1

Experimental 2

PLACEBO COMPARATOR

2 capsules of microcrystaline cellulose per day

Dietary Supplement: Experimental 2

Interventions

Experimental 1 DIETARY_SUPPLEMENT

Probiotic and riboflabin

Experimental 1

Experimental 2 DIETARY_SUPPLEMENT

Microcrystaline cellulose

Experimental 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for Health Sciences, Serbia: lead

MeSH Terms

Conditions

Cognition Disorders; Lymphoma, Follicular; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Nikola Todorovic, PhD

  Center for Mitochondrial Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergej Ostojic, MD, PhD

CONTACT

+381112643242; sergej.ostojic@chess.edu.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2026
• First Posted: February 13, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): August 15, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: Only qualified researchers with academic interest in nutritional science.