Acute and Chronic Effects of Ecologic Barrier© on Mood and Cognition (ProCog)

University of Reading

Status: Completed

Conditions: Cognitive Change; Mood

Treatments: Dietary Supplement: Placebo powder; Dietary Supplement: Ecologic Barrier©

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04951687

2-2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

Active: Ecologic Barrier©

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ecologic Barrier©

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo powder