Anti-inflammatory Probiotics in Cognitive Functioning

Summary

The goal of this study is to explore the potential impact of an anti-inflammatory probiotic mixture of psychobiotics including Bifidobacterium longum Rosell®-175 and Lactobacillus helveticus Rosell®-52 on cognitive functions in older adults following either pro-inflammatory or anti-inflammatory diets. According to recent findings, even short-term exposure to foods with pro- or anti-inflammatory properties may lead to corresponding negative or beneficial effects on cognitive functioning .

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.

Conditions

• Memory Decline
• Cognitive Decline
• Cognitive Aging

Interventions

DIETARY_SUPPLEMENT

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 × 10⁹ (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

DIETARY_SUPPLEMENT

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 × 10⁹ (3 billion) CFU\*. * Instructions: Take before 1:00 PM. Do not consume hot drinks immediately after taking the capsule. * CFU = Colony Forming Units

Sponsors & Collaborators

• Sanprobi Sp. z o. o.

  collaborator UNKNOWN

• National Science Centre, Poland

  collaborator OTHER_GOV

• University of Social Sciences and Humanities, Warsaw

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-25

Primary Completion

2025-09-30

Completion

2026-12-31

Countries

• Poland

Study Locations