None listed
Conditions
Brief summary
The interaction between the human brain and the bacteria within their gastrointestinal tract, otherwise known as the gut microbiome, has been emerging as a major factor in health and wellbeing. Fermented dairy products like yogurt contain “live cultures” of specific types of bacteria that interact with the human gut microbiome and by doing so, maybe potentially beneficial to their brain function, cognitive performance, and mood. To date, research on fermented dairy and brain measures is limited. For this reason, this study is interested in studying the possible impact of fermented dairy on measures of brain function and neurochemistry. This study will compare the possible effects of fermented dairy against a non-fermented dairy drink by measuring several areas of brain function. This study will also investigate possible differences between these groups on antioxidant capacity, cognitive performance, mood, and gut microbiota composition. This study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Forty female participants will complete an 8-week intervention, which will involve two face-to-face visits at the Monash Brain Park, Australia. Participants will be randomly assigned to one of two groups: one receiving a fermented dairy product (intervention) or a matched placebo (n = 20 per group). Findings from this study may be of particular relevance to the many Australians who suffer from depression, anxiety and stress. This research will also enable us to answer an important public health question; are fermented dairy products any better or worse for our health than conventional dairy products? This information will be useful for health professionals and policymakers and may shape future dietary guidelines.
Interventions
This study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Participants will be randomly assigned to two groups: one receiving a fermented dairy product (intervention) or a matched placebo (n = 20 per group). The participants will be required to consume 130g of the study intervention/placebo each morning for eight weeks. The intervention is a dairy milk beverage that has been fermented with >1 billion CFU of live active cultures (B. lactis (BB-12), S. Thermoph
This study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Participants will be randomly assigned to two groups: one receiving a fermented dairy product (intervention) or a matched placebo (n = 20 per group). The participants will be required to consume 130g of the study intervention/placebo each morning for eight weeks. The intervention is a dairy milk beverage that has been fermented with >1 billion CFU of live active cultures (B. lactis (BB-12), S. Thermophilus, L. Bulgaricus). Participants will be asked to complete the consumption diary during the eight weeks and be requested to hand over the completed diary at the final visit.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
• Healthy females aged 18 – 55 years • Absence of diagnosis of cognitive impairment • Absence of a major neurological disorder • Absence of diagnosis of any diagnosed psychiatric disorders • Absence of low mood according to PHQ-2 Questionnaire (score <3) • Absence of major gastrointestinal disorders (Irritable bowel syndrome, Crohn’s disease, etc.) • 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
Outcome results
None listed