Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition (ProCog)

The Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition

This study aims to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy adults.

Study Overview

• Status: Completed
• Conditions: Cognitive Change; Mood
• Intervention / Treatment: Dietary supplement: Ecologic Barrier©; Dietary supplement: Placebo powder

Detailed Description

This study will employ a double-blind, randomised, placebo-controlled crossover design to investigate the acute and chronic effects of an 8 week probiotic intervention (Ecologic Barrier©) on mood and cognitive outcomes in healthy older adults. A total of 30 participants will be enrolled and counterbalanced to receive the active probiotic treatment (2g per day Ecologic Barrier©) or a matched placebo in the first arm, before having a 4 week washout period and continuing with 8 weeks of the second treatment not consumed within the first arm. Outcome measures will be assessed at baseline, 24 hours and 8 weeks within each arm. These will include cognitive measures of affective processing, immediate and delayed verbal memory, visuospatial working memory and executive functions, and mood measures of depressive symptoms, cognitive reactivity, anxiety, stress and general mood. In addition, faecal samples will be collected at all timepoints in order to explore faecal microbiota profiles before and after probiotic treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG6 6BZ
    • School of Psychology and Clinical Languages

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 80 years (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged between 65 - 80
• Agree not to not consume probiotic or prebiotic supplements or live yoghurt throughout the course of study.
• Proficient in the English language

Exclusion Criteria:

• Already a habitual user of probiotics
• Antibiotic treatment within last 3 months
• Current diagnosis of and not currently receiving treatment for mental health disorder
• Gastrointestinal disorder
• Allergic to any ingredient of the active or placebo treatment
• Regular smoker
• Diabetes mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active: Ecologic Barrier©; Dietary supplement: Ecologic Barrier© Ingredients: maize starch, maltodextrin, vegetable protein, potassium chloride, magnesium sulphate, manganese sulphate, and probiotic bacteria (B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lc. lactis W19, Lc. lactis W58). Subjects will consume 2g (5 billion CFU)/day of Ecologic Barrier©. The intervention is a powder which is sealed in sachets and an be stored at room temperature by participants. Subjects are to mix into warm water and drinking alongside a meal.	Dietary supplement: Ecologic Barrier©; 5x10^9 CFU/ 2g per day of Ecologic Barrier©
Placebo Comparator: Placebo; Dietary supplement: placebo powder Ingredients: maize starch, maltodextrin, vegetable protein, potassium chloride, magnesium sulphate, manganese sulphate. As with the active treatment, the intervention is a powder which is sealed in sachets and an be stored at room temperature by participants. Subjects are to mix into warm water and drinking alongside a meal.	Dietary supplement: Placebo powder; matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Corsi Block Tapping Test performance	A standardised assessment of visuospatial working memory. The task comprises nine identical squares fixed in a random arrangement on a screen. Participants observe sequences of between two and nine blocks, which they then reproduce as accurately as possible. The dependent variable is the number of blocks pointed out in the correct order. Four versions of each sequence length are presented during the task. A novel sequence will be presented on each occasion, the order of which will be counterbalanced across participants.	Baseline, 24 hours and 8 weeks
Change in Immediate Word Recall from the Rey Auditory Verbal Learning Task	Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy.	Baseline, 24 hours and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rey Auditory Verbal Learning Task - Delayed Word Recall	After a period of time subject are asked to recall as many words as possible from list A	Baseline, 24 hours and 8 weeks
Rey Auditory Verbal Learning Task - Word Recognition	Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.	Baseline, 24 hours and 8 weeks
Switching task	This task requires executive function and sustained attention, and provides a measure of cognitive flexibility. Participants view a circle with 8 equally spaced radii 2 of which form a bold bisecting line. Numbers are chosen randomly from a set of 1-4 & 6-9 and displayed sequentially in a clockwise direction. A response of higher or lower than 5 is made for trials below the bold line, and even or odd for numbers above the line. Outcome measures include overall accuracy and reaction time (RT) on correct trials, as well as accuracy and RT on trials where there is a 'switch cost' from stimuli moving from below to above the bold line and vice versa.	Baseline, 24 hours and 8 weeks
Go/No Go task	This task measures executive function - specifically the ability to inhibit or withhold a response to no-go stimuli. Both a neutral block (white circles) and an emotional block (happy and fearful faces from the FACES database) are included here, in order to explore any additional influence of emotional stimuli on inhibitory responses. Outcome measures include accuracy and reaction time (RT). Accuracy and reaction times in the emotional blocks may also be correlated with responses to mood measures.	Baseline, 24 hours and 8 weeks
Leiden Index of Depression Sensitivity revised (LEIDS-r)	A validated questionnaire measure of cognitive reactivity. The LEIDS-r comprises of 34 items which the participant rate on a scale from 0-4 to indicate how strongly each statement applied to them when they are feeling somewhat sad.	Baseline, 24 hours and 8 weeks
Positive and Negative Affect Schedule expanded (PANAS-x)	A validated self-report measure of affective state. The PANAS comprises of two distinct affective states (positive and negative), as well as 11 individual affective states (fear, guilt, sadness, surprise, hostility, shyness, joviality, self-assurance, attentiveness, fatigue and serenity. Subjects use a likert scale from 1 - 5 to indicate how the word relates to how they are currently feeling. As this analysis is exploratory all affective states will be explored.	Baseline, 24 hours and 8 weeks
State Trait Anxiety Inventory	A well validated scale for assessing self-reported state and trait anxiety. In line with the study objectives, only the state items will be used to assess current feelings of anxiety in the participants. This includes 10 items which are rated using a 4-point likert scale.	Baseline, 24 hours and 8 weeks
Perceived Stress Scale	A validated 10 item scale for self-reporting levels of perceived stress over the last month. Items are rated using a 5-point likert scale.	Baseline and 8 weeks
Centre for Epidemiological Studies Depression Scale (CESD)	A validated, brief self report measure of depressive symptoms commonly used to assess sub-clinical levels of low mood. Items are responded to using a 4-point likert scale. Scores range from 0 to 60, with high scores indicating greater depressive symptoms.	Baseline and 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal sample analysis	16S rRNA sequencing for classification and quantification of faecal bacteria	Baseline, 8 weeks
Montreal Cognitive Assessment	The Montreal Cognitive Assessment (MoCA) is a short cognitive screening tool to indicate current cognitive status. It is similar to the Mini Mental State Examination, but more sensitive to Mild Cognitive Impairment. Results will not be used to screen for eligibility, but baseline MoCA score may be included as covariate.	Baseline (arm 1 only)
Epic-Norfolk Food Frequency Questionnaire (FFQ)	The FFQ is a validated tool for gauging the average habitual dietary intake of micro and macronutrients of an individual in the UK, which is particularly important to explore in order to understand how the probiotic supplement may interact with diet and gut microbiome diversity. Data will be processed using the FETA software.	Baseline (arm 1 only)

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: Winclove Probiotics B.V.
• Investigators: Principal Investigator: Daniel Lamport, Associate Prof, University of Reading; Study Director: Saskia Van Hemert, Winclove Probiotics B.V.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No