Investigating the effect of fermented dairy on brain structure and functio

Not Applicable

Completed

• Conditions: Mental health; Mental Health - Anxiety; Mental Health - Depression

• Registration Number: ACTRN12622000622707
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-27
• Study Completion: 2022-12-21
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

•Healthy females aged 18 – 55 years
•No cognitive impairment (MMSE score > 24)
•Absence of a major neurological disorder
•Absence of mood disturbance (BDI score >9)
•Absence of major gastrointestinal disorders (Irritable bowel syndrome, Crohn’s disease, etc.)
•Right handed
•Deemed safe and comfortable to undergo an MRI
•Willing to maintain their habitual diet and level of exercise
•Willing and able to comply with study procedures
•Able to provide voluntary informed consent
•English speaking or non-English speaking patients that can ensure external interpreter assistance (e.g. from a relative, spouse or friend) for the onsite clinical visits and for the phone follow-up timepoints.

Exclusion Criteria

•Use of probiotics or antibiotics in last 2 weeks (eligible following a 4-week washout/discontinuation period)
•Recently commenced a new supplement known to influence gut/brain health (eligible following a 4-week washout/discontinuation period)
•Consuming fermented dairy on a regular basis (eligible following a 4-week washout/discontinuation period)
•Unable or unlikely to attend the required study visits at the required timepoints or unable to complete the study protocol (e.g. upcoming travel, surgery)
•History of neurological illness or moderate – severe brain injury (i.e. no LOC, PTA or ongoing cognitive/neurological impairment),
•Allergy to dairy or lactose intolerance or allergy/intolerance to any study components
•Have a major unstable medical illness that is likely to impact on ability to adhere to study protocol or the study outcome measures
•Severe claustrophobia, non-MR compatible metallic implant , or other contraindication to MRI scanning,
•Lifetime diagnosis of learning difficulty, ADHD, or other condition involving cognitive impairment as a primary feature,
•Pregnancy or breastfeeding
•Sustained a head injury through TBI, concussion
•Participation in another study using an investigational product
•Left handed
•Pacemaker, aneurysm clip or anything that may interfere with the safety for MRI or quality of the images
•Any other reason that the investigator deems the individual unsuitable to be enrolled

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in concentration of major brain metabolites (N-acetylaspartic acid, choline, creatine, myo-inositol, glutamate and glutamine) at left hippocampus measured by magnetic resonance spectroscopy between intervention and placebo groups. <br>[ 8-weeks post-baseline<br>]