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

NCT04951687 | Completed

• 1 other identifier: 2-2020
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Mood

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Rey Auditory Verbal Learning Task - Delayed Word Recall

  Baseline, 24 hours and 8 weeks

• Rey Auditory Verbal Learning Task - Word Recognition

  Baseline, 24 hours and 8 weeks

• Switching task

  Baseline, 24 hours and 8 weeks

• Go/No Go task

  Baseline, 24 hours and 8 weeks

• Leiden Index of Depression Sensitivity revised (LEIDS-r)

  Baseline, 24 hours and 8 weeks

Other Outcomes (3)

• Faecal sample analysis

  Baseline, 8 weeks

• Montreal Cognitive Assessment

  Baseline (arm 1 only)

• Epic-Norfolk Food Frequency Questionnaire (FFQ)

  Baseline (arm 1 only)

Study Arms (2)

Active: Ecologic Barrier©

EXPERIMENTAL

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©

Placebo

PLACEBO COMPARATOR

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

Interventions

Ecologic Barrier© DIETARY_SUPPLEMENT

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

Active: Ecologic Barrier©

Placebo powder DIETARY_SUPPLEMENT

matched placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead
• Winclove Probiotics B.V.: collaborator

Study Sites (1)

School of Psychology and Clinical Languages

Reading, RG6 6BZ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40222448 DERIVED

Study Officials

• Daniel Lamport, Associate Prof

  University of Reading

  PRINCIPAL INVESTIGATOR

• Saskia Van Hemert

  Winclove Probiotics B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: July 7, 2021
• Study Start: August 5, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)