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Completed

NCT Number: NCT04951687

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.

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Key information

Conditions

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Psychology and Clinical Languages

Reading, RG6 6BZ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ecologic Barrier©

Dietary Supplement

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

Placebo Powder

Dietary Supplement

matched placebo

Primary outcomes

  1. Change in Corsi Block Tapping Test performance

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  2. Change in Immediate Word Recall from the Rey Auditory Verbal Learning Task

    Time frame: Baseline, 24 hours and 8 weeks

    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.

Secondary outcomes

  1. Rey Auditory Verbal Learning Task - Delayed Word Recall

    Time frame: Baseline, 24 hours and 8 weeks

    After a period of time subject are asked to recall as many words as possible from list A

  2. Rey Auditory Verbal Learning Task - Word Recognition

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  3. Switching task

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  4. Go/No Go task

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  5. Leiden Index of Depression Sensitivity revised (LEIDS-r)

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  6. Positive and Negative Affect Schedule expanded (PANAS-x)

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  7. State Trait Anxiety Inventory

    Time frame: Baseline, 24 hours and 8 weeks

    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.

  8. Perceived Stress Scale

    Time frame: Baseline and 8 weeks

    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.

  9. Centre for Epidemiological Studies Depression Scale (CESD)

    Time frame: Baseline and 8 weeks

    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.

Other outcomes

  1. Faecal sample analysis

    Time frame: Baseline, 8 weeks

    16S rRNA sequencing for classification and quantification of faecal bacteria

  2. Montreal Cognitive Assessment

    Time frame: Baseline (arm 1 only)

    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.

  3. Epic-Norfolk Food Frequency Questionnaire (FFQ)

    Time frame: Baseline (arm 1 only)

    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.

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Winclove Probiotics B.V.

Registry information

Official study title

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

Acronym: ProCog

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2021
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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