Probiotic supplementation with Leuconostoc mesenteroides OL3621 and cognitive performance in community-dwelling older adults
| ISRCTN | ISRCTN10663155 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10663155 |
| Sponsor | Olimp Laboratories Sp. z o.o. |
| Funder | Narodowe Centrum Badań i Rozwoju |
- Submission date
- 04/03/2026
- Registration date
- 05/03/2026
- Last edited
- 05/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Plain English summary of protocol not provided at time of registration
Contact information
Prof Andrzej Małecki
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
Laboratory of Molecular Biology, Institute of Physiotherapy and Health Sciences, Academy of Physical Education, Mikołowska 72a
Katowice
40-065
Poland
| Phone | +48322075435 |
|---|---|
| a.malecki@awf.katowice.pl |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Placebo |
| Assignment | Parallel |
| Purpose | Basic science, Prevention, Treatment |
| Scientific title | 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. |
| Study objectives | This is an exploratory pilot study; secondary outcomes are hypothesis-generating. |
| Ethics approval(s) |
Approved 23/06/2022, University Bioethics Committee for Scientific Research (ul. Mikołowska 72A, Katowice, 40-065, Poland; +48322075433; komisjabioetyczna@awf.katowice.pl), ref: Resolution No. 6/2022 |
| Health condition(s) or problem(s) studied | Influence of Leuconostoc mesenteroides OL3621 on cognitive performance in community-dwelling older adults. |
| Intervention | 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 assigning participants to one of the two groups: 1. Probiotic group: tested formulation had a pharmaceutical form of capsules, containing Leuconostoc mesenteroides OL3621 (deposit number: KPD 1758) lyophilizate, maltodextrin, magnesium stearate and silicon oxide (1,4 × 10^10 CFU per day; 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 substituted by maltodextrin (taken orally as a 370 mg capsule twice a day: morning and evening) |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 15/11/2023 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 55 Years |
| Upper age limit | 85 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2023 |
| Date of final enrolment | 15/07/2023 |
Locations
Countries of recruitment
- Poland
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
04/03/2026: Study’s existence confirmed by the University Bioethics Committee for Scientific Research at the Jerzy Kukuczka University of Physical Education in Katowice, Poland.
