Anti-inflammatory Probiotics in Cognitive Functioning (CoProM)

University of Social Sciences and Humanities, Warsaw

Status: Active, not recruiting

Conditions: Cognitive Aging; Cognitive Decline; Memory Decline

Treatments: Dietary Supplement: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52); Dietary Supplement: Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07165977

2021/43/O/HS6/02074 (Other Grant/Funding Number)

Cognition-Probiotic-Microbiota

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 50 or older
• 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

• Regular use of prebiotics, antibiotics, or antifungal medications
• Use of prebiotics, antibiotics, or antifungal medications within the past 3 months
• Diagnosed neurological disorder
• History of head injury with neurological consequences
• Left-handedness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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110 participants in 4 patient groups

Anti-inflammatory diet + probiotic first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo

Anti-inflammatory diet + placebo first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)

Pro-inflammatory diet + probiotic first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52) then placebo

Pro-inflammatory diet + placebo first

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Placebo Supplementation then Probiotic Supplementation (Bifidobacterium longum Rosell®-175 & Lactobacillus helveticus Rosell®-52)