Recent evidence suggests multi-strain probiotics containing Lactobacillus rhamnosus and Bifidobacterium longum have been found to enhance emotional processing and reduce salience to negative cues in studies involving people with mood disorders, as well as improve cognitive functions, such as memory and concentration, in healthy participants. By administering computer-based tasks, questionnaires and checking biological measures (cortisol, immune markers, blood metabolites, gut microbiota) using blood and faecal samples, this experimental medicine study aims to investigate whether a probiotic supplement has an effect on emotional processing and cognition in perimenopausal women. We also aim to study changes in gut bacteria from stool samples before and after taking the supplement to see if any microbiome changes are associated with any effects in emotional processing, cognitive function, and biological markers.
Female at birth
You are aged 45-60 years and in perimenopause (determined by changes in menstrual bleeding patterns (such as changes in cycle length of 7 days or longer in either direction from what is normal for you), AND vasomotor symptoms (e.g., hot flushes and sweats) AND mild to moderate mood or cognitive disturbances, or joint and muscle pain over the previous 12 months)
You are willing and able to give informed consent for participation in the study
You are sufficiently fluent in English to understand and complete tasks
Currently receive or seek treatment for any mental health condition
Have a BMI >=30 OR <=18.5
Have lost or gained more than 10% of body weight in a short period (e.g., 6 months), as this can affect mood and cognition
Currently using hormonal contraception or have used hormonal contraception in the last 6 months
Parallel
Multi-strain probiotic
Dietary supplementA commercially available probiotic known to support gut health and is generally well-tolerated.
Placebo
Dietary supplementA microcrystalline cellulose-based capsule.
Facial Expression Recognition Task (FERT)
Accuracy, reaction time and misclassifications on the FERT compared between probiotic and placebo groups.
Emotional Categorisation Task
Accuracy and reaction time performance on emotional word categorization task compared between probiotic and placebo groups.
Emotional word recall/recognition task
Performance on emotional word recall (hits and false alarms) and recogntion (hits, false alarms and reaction time) compared between probiotic and placebo groups
Digit Span Task
Maximum span length compared between probiotic and placebo groups
Emotional Go/No-Go (EGNG)
Cognitive control and inhibitory control assessed using the EGNG task, including commission errors, omission errors, and reaction time to emotionally valenced stimuli. Performance will be compared between probiotic and placebo groups at post-intervention.
Subjective measures of affective state
Questionnaire measures of affect (PANAS) compared between placebo and probiotic groups
Subjective measures of mood
Questionnaire measures of mood (PANAS) compared between placebo and probiotic groups
Subjective measures of menopausal symptom severity
Questionnaire measures of menopausal symptom severity (MRS) compared between placebo and probiotic groups
Subjective measures of cognitive state
Questionnaire measures of subjective cognitive difficulties (PDQ) compared between placebo and probiotic groups
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University of Oxford
Lead sponsor
ADM Protexin
Collaborator
