The Moo’D Study: protocol for a randomised controlled trial of A2 beta-casein only versus conventional dairy products in women with low mood

Trials

Mohammadreza Mohebbi¹  Helen Macpherson²  Hajara Aslam³  Adrienne O’Neil³  Meghan Hockey³  Wolfgang Marx³  Amelia J. McGuinness³  Lauren M. Young³  Tetyana Rocks³  Felice N. Jacka³  Julie A. Pasco⁴  Mary Lou Chatterton⁵  Anu Ruusunen⁶  Michael Berk⁷ 

[1] Biostatistics Unit, Faculty of Health, Deakin University, 3125, Burwood, VIC, Australia;Institute for Physical Activity and Nutrition, Faculty of Health, Deakin University, 3125, Burwood, VIC, Australia;The Food & Mood Centre, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;The Food & Mood Centre, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;Department of Epidemiology and Preventive Medicine, Monash University, Prahran, VIC, Australia;Department of Medicine-Western Health, The University of Melbourne, St Albans, VIC, Australia;The Food & Mood Centre, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;Institute for Health Transformation, Faculty of Health, Deakin University, Geelong, Australia;The Food & Mood Centre, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;Institute of Public Health and Clinical Nutrition, University of Eastern Finland, Kuopio, Finland;Department of Psychiatry, Kuopio University Hospital, Kuopio, Finland;The Food & Mood Centre, IMPACT (the Institute for Mental and Physical Health and Clinical Translation), School of Medicine, Barwon Health, Deakin University, Geelong, Australia;Orygen, The National Centre of Excellence in Youth Mental Health, Centre for Youth Mental Health, Florey Institute for Neuroscience and Mental Health and the Department of Psychiatry, The University of Melbourne, Melbourne, Australia;

关键词: Beta-casein;    Milk;    Dairy;    Psychological distress;    Inflammation;    Gut microbiota;    Depression;    Psychiatry;    Mental disorders;    Randomised controlled trial;   

DOI  :  10.1186/s13063-021-05812-6

来源: Springer

【 摘 要 】

BackgroundBeta-casein is a major protein in cow’s milk, of which A1 and A2 are the most frequent variants. Recent evidence implicates A1 beta-casein consumption in mechanisms that are of potential importance to mental health, yet its possible effects on psychological endpoints remains unknown. The primary aim of the study is to evaluate the comparative effects of consumption of dairy products containing A2 beta-casein versus conventional dairy (i.e. containing both A1 and A2 beta-casein) on symptoms of psychological distress in women with low mood.Methods‘The Moo’D Study’ is a 16-week, superiority, 1:1 parallel group, triple-blinded, randomised controlled trial. Ninety women with low mood (Patient Health Questionnaire score ≥ 5) will be randomised to consume either A2 beta-casein only or conventional dairy products. The primary outcome, symptoms of psychological distress, will be measured by the 21-item Depression, Anxiety and Stress Scale. Secondary outcomes will include symptoms of depression, anxiety and stress, severity of low mood, cognition, gut microbiota composition, gut symptomatology, markers of immune function, gut inflammation, systemic metabolites, endothelial integrity and oxidative stress, body composition, perceived wellbeing, sleep, quality of life, resource use and cost-effectiveness.DiscussionThis study will advance our understanding of the possible impact of milk proteins on psychological distress in women as well as elucidate mechanisms underpinning any association. Given dairy products form a substantial component of traditional and Western diets, the implications of these findings are likely to be of clinical and public health importance.Trial registrationThe trial protocol has been prospectively registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12618002023235. Registered on 17 December 2018.

【 授权许可】

CC BY