Clinical trial NCT04951687: Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition
Official title: The Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Mood
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Winclove Probiotics B.V.
First posted: 2021-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Corsi Block Tapping Test performance
timeFrame: Baseline, 24 hours and 8 weeks
measure: Change in Immediate Word Recall from the Rey Auditory Verbal Learning Task
timeFrame: Baseline, 24 hours and 8 weeks
Secondary outcomes:
measure: Rey Auditory Verbal Learning Task - Delayed Word Recall
timeFrame: Baseline, 24 hours and 8 weeks
measure: Rey Auditory Verbal Learning Task - Word Recognition
timeFrame: Baseline, 24 hours and 8 weeks
measure: Switching task
timeFrame: Baseline, 24 hours and 8 weeks
measure: Go/No Go task
timeFrame: Baseline, 24 hours and 8 weeks
measure: Leiden Index of Depression Sensitivity revised (LEIDS-r)
timeFrame: Baseline, 24 hours and 8 weeks
measure: Positive and Negative Affect Schedule expanded (PANAS-x)
timeFrame: Baseline, 24 hours and 8 weeks
measure: State Trait Anxiety Inventory
timeFrame: Baseline, 24 hours and 8 weeks
measure: Perceived Stress Scale
timeFrame: Baseline and 8 weeks
measure: Centre for Epidemiological Studies Depression Scale (CESD)
timeFrame: Baseline and 8 weeks
Other outcomes:
measure: Faecal sample analysis
timeFrame: Baseline, 8 weeks
measure: Montreal Cognitive Assessment
timeFrame: Baseline (arm 1 only)
measure: Epic-Norfolk Food Frequency Questionnaire (FFQ)
timeFrame: Baseline (arm 1 only)
Locations:
city: Reading
country: United Kingdom
facility: School of Psychology and Clinical Languages
Study officials:
affiliation: University of Reading
name: Daniel Lamport, Associate Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Winclove Probiotics B.V.
name: Saskia Van Hemert
role: STUDY_DIRECTOR
References: