Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
110 participants
INTERVENTIONAL
2024-01-25
2026-12-31
Brief Summary
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The main questions this study aims to answer are:
* How important is the initial dietary pattern for observing possible beneficial effects of probiotic supplementation? (Diet as a potential moderator)
* How important is the initial state of the gut microbiota for observing possible beneficial effects of probiotic supplementation? (Microbiota as a potential moderator)
* Is it possible to improve or slow down the decline in cognitive functions associated with aging with probiotic supplementation?
* Can probiotic supplementation counteract the negative effects of pro-inflammatory dietary patterns?
The investigators will compare probiotic to a placebo (a look-alike substance that contains no active ingredients) to determine whether probiotic is effective in enhancing cognitive function.
Participants:
* Take a probiotic or placebo capsule daily for 3 months
* Undergo a crossover after 3 months - those who initially took probiotics will switch to the placebo, and vice versa
* Visit SWPS University for screening (T0), baseline assessments before beginning supplementation (T1), and follow-up assessments at 3 months (T2) and 6 months (T3). The T2 visit occurs just before the crossover.
* Complete neuropsychological testing, questionnaires, and EEG recordings during the T1, T2, and T3 visits.
* Provide stool samples for gut microbiota analysis at the T1, T2, and T3 visits.
* Maintain their usual dietary habits throughout the study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
TRIPLE
Study Groups
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Anti-inflammatory diet + probiotic first
This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study.
Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo
Each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for another 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Anti-inflammatory diet + placebo first
This is a group of participants whose everyday dietary pattern was assessed as anti-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study.
Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)
Each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for another 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Pro-inflammatory diet + probiotic first
This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive probiotics during the first 3 months of the study.
Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo
Each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for another 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Pro-inflammatory diet + placebo first
This is a group of participants whose everyday dietary pattern was assessed as pro-inflammatory based on the Shivappa et al. (2014) equation, and who will receive placebo during the first 3 months of the study.
Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)
Each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for another 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Interventions
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Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo
Each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for another 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)
Each participant will take a probiotic containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell for 3 months.
* Dosage: One capsule per day.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
After completion of the first phase, each participant will take a probiotic mixture containing Bifidobacterium longum Rosell®-175 \& Lactobacillus helveticus Rosell®-52 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) for another 3 months.
* Dosage: One capsule per day, containing 3 × 10⹠(3 billion) CFU\*.
* Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule.
* CFU = Colony Forming Units
Eligibility Criteria
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Inclusion Criteria
* Signed written Informed Consent Form
* Score ≥28 on the Mini-Mental State Examination (MMSE)
* A willingness and motivation to follow the study protocol
Exclusion Criteria
* Use of prebiotics, antibiotics, or antifungal medications within the past 3 months
* Diagnosed neurological disorder
* History of head injury with neurological consequences
* Left-handedness
50 Years
ALL
Yes
Sponsors
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Sanprobi Sp. z o. o.
UNKNOWN
National Science Centre, Poland
OTHER_GOV
University of Social Sciences and Humanities, Warsaw
OTHER
Responsible Party
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Aneta Brzezicka
Associate professor, Head of the Neurocognitive Research Center at SWPS University
Locations
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SWPS University
Warsaw, Masovian Voivodeship, Poland
Countries
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Other Identifiers
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2021/43/O/HS6/02074
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Cognition-Probiotic-Microbiota
Identifier Type: -
Identifier Source: org_study_id
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