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Cognitive ChangeProCogNCT04951687

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

A study testing Ecologic Barrier© in people with Cognitive Change and Mood, run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Change, Mood
What is being tested?
Ecologic Barrier©
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteUnited Kingdom
Study dates
5 Aug 2021to 1 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • School of Psychology and Clinical Languages

    Reading, RG6 6BZ

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Ecologic Barrier©, Placebo powder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecologic Barrier©Dietary supplement

    5x10^9 CFU/ 2g per day of Ecologic Barrier©

  • Placebo powderDietary supplement

    matched placebo

Study groups in NCT04951687
Study groupRoleWhat they receive
Active: Ecologic Barrier©ExperimentalDietary 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.
Receives: Dietary Supplement: Ecologic Barrier©
PlaceboPlacebo comparatorDietary 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.
Receives: Dietary Supplement: Placebo powder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 24 hours and 8 weeks

  2. 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.

    Measured: Baseline, 24 hours and 8 weeks

Secondary outcomes (9)

  1. 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

    Measured: Baseline, 24 hours and 8 weeks

  2. 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.

    Measured: Baseline, 24 hours and 8 weeks

  3. 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.

    Measured: Baseline, 24 hours and 8 weeks

  4. 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.

    Measured: Baseline, 24 hours and 8 weeks

  5. 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.

    Measured: Baseline, 24 hours and 8 weeks

  6. 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.

    Measured: Baseline, 24 hours and 8 weeks

  7. 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.

    Measured: Baseline, 24 hours and 8 weeks

  8. 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.

    Measured: Baseline and 8 weeks

  9. 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.

    Measured: Baseline and 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2021
  2. Study start5 Aug 2021
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04951687
Sponsor's protocol ID
2-2020
Acronym
ProCog
Status last verified
May 2023
First submitted
11 May 2021
Last updated
23 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eastwood J, van Hemert S, Stolaki M, Williams C, Walton G, Lamport D. Exploring the acute and chronic effects of a multistrain probiotic supplement on cognitive function and mood in healthy older adults: a randomized controlled trial. Am J Clin Nutr. 2025 Jun;121(6):1268-1280. doi: 10.1016/j.ajcnut.2025.04.002. Epub 2025 Apr 11.

    PubMed 40222448

Questions about this trial

What is this clinical trial studying?

A study testing Ecologic Barrier© in people with Cognitive Change and Mood, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Corsi Block Tapping Test performance (time frame: Baseline, 24 hours and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04951687, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.

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