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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-05

Study Completion Date

2022-07-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cognitive Change Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ecologic Barrier©

Intervention Type DIETARY_SUPPLEMENT

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

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.

Group Type PLACEBO_COMPARATOR

Placebo powder

Intervention Type DIETARY_SUPPLEMENT

matched placebo

Interventions

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Ecologic Barrier©

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

Intervention Type DIETARY_SUPPLEMENT

Placebo powder

matched placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes