The Effects of Lactobacillus Rhamnosus (JB-1) on Stress and Cognition
- Conditions
- Healthy
- Interventions
- Dietary Supplement: Lactobacillus Rhamnosus (JB-1)Dietary Supplement: Placebo
- Registration Number
- NCT03160066
- Lead Sponsor
- University College Cork
- Brief Summary
Emerging evidence suggests that microorganisms acting via the Brain-Gut axis may have potential benefits for the management of stress-related conditions. The majority of studies have focused on animal models. Preclinical studies have identified the Lactobacillus Rhamnosus JB-1 strain as a putative psychobiotic with an impact on stress-related behaviours, physiology and cognitive performance. Whether such preclinical effects could be translated to healthy human volunteers remains unknown.
- Detailed Description
30 healthy male volunteers will be recruited in a randomized single blind placebo controlled cross over trial. Study participation will involve a screening visit followed by a baseline cognitive test battery, EEG and stress visit (socially evaluated cold-pressor test). These measures will be repeated after 4 weeks of daily probiotic and placebo capsules.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 29
- able to give informed written consent
- able to speak English
- having a significant acute or chronic illness
- following a diet or taking a medication that would interfere with study objectives
- pose a safety risk or confound the interpretation of the study results
- evidence of immunodeficiency, bleeding disorder or coagulopathy
- English not being participant's first language
- colour blindness
- dyslexia or dyscalculia
- taking any probiotic products or antibiotics in the last 4 weeks
- receiving any treatment involving experimental drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Active Lactobacillus Rhamnosus (JB-1) Capsules containing 1x10\^9 colony forming units of Lactobacillus Rhamnosus (JB-1) will be given once per day for 4 weeks. Placebo Placebo Placebo capsules identical to the probiotic in taste, smell, colour, and comprised only of the same non-active ingredients (corn starch, magnesium stearate and silicon dioxide) in the probiotic supplement will be given once per day for 4 weeks.
- Primary Outcome Measures
Name Time Method Change in Cognition Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment A battery of cognitive tests will be assessed using the Cambridge Neuropsychological Test Automated Battery
- Secondary Outcome Measures
Name Time Method Change in the Inflammatory profile Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment Cytokine levels and toll-like receptor activity
Change in Salivary cortisol concentrations Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment Salivary cortisol will be collected before and after the socially evaluated cold pressor procedure.
Changes in Mood Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment Beck Depression Inventory
Changes in Anxiety Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment Beck Anxiety Inventory
Change in Electroencephalography (EEG) Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment EEG measures of absolute power in the delta (1.5-3.5Hz), theta (4-7.5Hz), alpha1 (8- 9.5Hz), alpha2 (10-12.5Hz), beta1 (13-17.5Hz), and beta2 (18-25.5Hz) frequency bands
Changes in Stress levels Change from Baseline, after 4 weeks of initial treatment and after 4 weeks of second treatment Perceived Stress Scale
Trial Locations
- Locations (1)
APC Microbiome Institute
🇮🇪Cork, Ireland