A Supplement on Cognitive Function and Brain Activity in Middle Age and Older Healthy Adults

Summary

PoZibio™ capsules contains Lactobacillus paracasei which has been heat-killed (post-biotic).

The researchers will recruit a cohort of middle aged and older adults (\>50 years) who will be randomised into PoZibio™ (2 x capsules daily) or placebo (2 x capsules daily) supplementation for 6 weeks. Subjects will be asked to take both capsules in the morning with their breakfast. The placebo will be matched to the active product by taste and texture.

Electroencephalography (EEG) shall be combined with 3 psychological tasks, to measure a variety of cognitive domains including attention, processing speed, accuracy, and response inhibition. These psychological tasks shall include the Stroop task, the Go/No-go task, and the Flanker task. Before taking part in the psychological tasks, participants shall be required to have their EEG resting state recorded, requiring them to participate in an Eyes Open/Closed Task.

The Mini Mental State Exam (MMSE) questionnaire shall be used as a digital screening tool to assess global cognitive function in participants both prior to and following the 6-week PoZibio trial. The geriatric depression scale (GDS) shall also be used as a digital screening tool to assess for depressive symptomatology in older adults. The EQ-5D questionnaire shall be used to obtain an overall profile of the health state and quality of life of participants before and after the trial.

The researchers will collect venous blood samples for the investigation into the chemical composition using metabolomics, the quantification of short chain fatty acids as well as clinical biochemistry, before and after the trial.

Aim:

A randomised, placebo controlled parallel human clinical trial of heat-treated Lactobacillus paracasei (post-biotics) in healthy middle aged and older subjects is proposed, to assess the potential for clinically relevant benefits in terms of cognitive function.

Conditions

• Cognitive Decline

Interventions

DIETARY_SUPPLEMENT

PoZibio

PoZibio (50 x 10\^9 CFUs/ CAPSULE)

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

• AGROCEUTICAL PRODUCTS LTD

  collaborator UNKNOWN

• Neurodyn Life Sciences Inc.

  collaborator UNKNOWN

• Postbiotics Inc

  collaborator UNKNOWN

• Welsh Government

  collaborator UNKNOWN

• Aberystwyth University

  lead OTHER

Principal Investigators

• Amanda J Lloyd, PhD, BSc · Aberystwyth University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-15

Primary Completion

2023-12-31

Completion

2023-12-31

Countries

• United Kingdom

Study Locations