Employing Milk Proteins to Observe Wellbeing and Emotional Resilience in healthy adults

AIMS This study aims to investigate the relationship between Milk Fat Globular Membrane (MFGM) supplementation, psychological wellbeing, sleep, and cognitive function in healthy adults. The study will be hypothesis generating and inform future larger trials. METHODS This study has been designed to run under any public health restrictions during the global pandemic. It will be a nationwide study, where all questionnaires, assessments, and interviews can be done remotely and via zoom. This allows a broader population for recruitment and minimises the impact of changing alert levels on data collection. This study has three data collection time points: baseline, mid-intervention, and post-intervention. Baseline Assessment: Timepoint one Once consent and demographic data collection is complete, participants will be sent a wearable Fitbit Charge 4 wrist watch, with instructions to wear it for two weeks to provide pre-study reference data. After the two-week Fitbit reference data collection period, participants will be sent a link to complete baseline questionnaires (DASS, WHO-5, PSQ), a separate link to complete cognitive assessment measures (Cambridge Neuropsychological Test Automated Battery CANTAB), and a posted home saliva cortisol test kit with instructions and postage paid return pack. Participants will be sent the supplement sachets at this time point. Intervention: Participants will be randomly assigned to receive 600mg of MFGM supplement, 1200mg of MFGM supplement, or placebo. Participants will be asked to take the powder daily, with food or drink for 12 weeks. Fonterra co-operative Group Limited will provide the MFGM supplement and placebo and all products will be manufactured to pharmaceutical grade. Lipid 100 is the name for the MFGM Fonterra product which is Buttermilk. Buttermilk contains about 20% MFGM and the rest is lactose and protein and other naturally occurring fats. Both the MFGM powder and placebo powder are gluten free and can be mixed with food or drink. Adherence Monitoring: Email or text messages (according to participant preference) will be sent fortnightly to remind participants to take the supplement daily. Mid-point assessment: At the mid-point of the intervention (6 weeks after starting the supplement) participants will be sent out a saliva collection kit to provide a sample and send it back. Participants will also be sent a link to complete the same questionnaires as they did at baseline (DASS, WHO-5, PSQ). Post-intervention Assessment: One week before the participant is due to complete the intervention, saliva collection kits will be sent out. Participants will be asked to collect the saliva sample and send it back using the pre-paid postage bag provided. At the end of the intervention period, participants will be sent an electronic link to complete the cognitive assessment (CANTAB) and the same questionnaires as they did at baseline (DASS, WHO-5, PSQ). Participants will select an appointment time for a post-intervention interview This can be done in person or via zoom according to participant preference. Participants will be guided through a semi-structured interview about general well-being, stress, and sleep quality that consists of 14 questions and should last up to 30 minutes in duration.