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Probiotic supplementation with Leuconostoc mesenteroides OL3621 and cognitive performance in community-dwelling older adults

A randomized, double-blind, placebo-controlled pilot trial evaluating the effect of Leuconostoc mesenteroides OL3621 on ACE-III cognitive performance and gut–redox biomarkers in community-dwelling older adults.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10663155
Enrollment
30
Registered
2026-03-05
Start date
2023-06-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influence of Leuconostoc mesenteroides OL3621 on cognitive performance in community-dwelling older adults. Other

Interventions

Randomization: computer-generated permuted-block method (block size = 4) to ensure a 1:1 allocation ratio. Group assignments: double blinded. A trained research assistant was responsible for assignin
taken orally as a 370 mg capsule containing 7 × 10^9 CFU/capsule twice a day: morning and evening) 2. Placebo group: placebo capsules contained equal mass of fulfillment, while probiotic was substitut

Sponsors

Olimp Laboratories Sp. z o.o.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age between 55 and 85 years 2. Free from diagnosed Alzheimer’s disease (as defined by NINCDS-ADRDA criteria) 3. Free from Parkinson’s disease (according to UK PDS BB criteria) 4. Mini-Mental State Examination (MMSE) score above 24

Exclusion criteria

Exclusion criteria: 1. Clinically confirmed diabetes 2. Active substance abuse 3. Unstable ischemic heart disease 4. Uncontrolled hypertension 5. History of severe allergic reactions, or any other serious medical conditions that, in the investigator’s opinion, might interfere with study procedures or supplement tolerability 6. Use of psychotropic drugs 7. Use of antibiotics and probiotics during the past 3 months 8. Major changes in diet in the last 3 months

Countries

Poland

Contacts

Public ContactAndrzej Malecki
a.malecki@awf.katowice.pl+48322075435

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026