TY - JOUR
T1 - The Moo’D Study: protocol for a randomised controlled trial of A2 beta-casein only versus conventional dairy products in women with low mood
AU - Hockey, Meghan
AU - Aslam, Hajara
AU - Berk, Michael
AU - Pasco, Julie A.
AU - Ruusunen, Anu
AU - Mohebbi, Mohammadreza
AU - Macpherson, Helen
AU - Chatterton, Mary Lou
AU - Marx, Wolfgang
AU - O’Neil, Adrienne
AU - Rocks, Tetyana
AU - McGuinness, Amelia J.
AU - Young, Lauren M.
AU - Jacka, Felice N.
N1 - Funding Information:
Deakin University have completed The Moo’D Study with funding from The a2 Milk Company. The a2 Milk Company also provided, in-kind, the investigational dairy products (intervention and control) for the duration of the study. The donors played no role in study design or data collection and will play no role in data analysis or reporting of the results. Donor: The a2 Milk Company Limited – NZ Co. No. 1014105, NZBN: 9429037368845. MH is supported by an Australian Rotary Health PhD Scholarship. HA is supported by Deakin University Postgraduate Industry Research Scholarship. MB is supported by a NHMRC Senior Principal Research Fellowship (1059660 and 1156072). HM is supported by a NHMRC-ARC Dementia training fellowship. Felice N Jacka is supported by an NHMRC Investigator Grant (#1194982). HA is supported by Deakin University Postgraduate Industrial Research Scholarship. AJM is supported by an Australian Rotary Health/Ten Island Tassie Tag Along Tour Funding Partner PhD Scholarship. WM is currently funded by an Alfred Deakin Postdoctoral Research Fellowship and a Multiple Sclerosis Research Australia early-career fellowship. LMY is supported by an Australian Research Training Program Stipend. AO is supported by a Future Leader Fellowship (#101160) from the Heart Foundation Australia and Wilson Foundation.
Funding Information:
JAP has recently received Grant/Research support from the University of Melbourne, Deakin University, Barwon Health, Amgen-GSK OA-ANZBMS, Amgen Australia, the Geelong Community Foundation, the Norman Beischer Medical Research Foundation, the National Health and Medical Research Council (NHMRC) and the Medical Research Future Fund (MRFF). FNJ has received Grant/Research support from the Brain and Behaviour Research Institute, the National Health and Medical Research Council (NHMRC), Australian Rotary Health, the Geelong Medical Research Foundation, the Ian Potter Foundation, Eli Lilly, Meat and Livestock Australia, Woolworths Limited, the Fernwood Foundation, Wilson Foundation, the A2 Milk Company, Be Fit Foods, and The University of Melbourne, and has received speakers honoraria from Sanofi-Synthelabo, Janssen Cilag, Servier, Pfizer, Health Ed, Network Nutrition, Angelini Farmaceutica, Eli Lilly and Metagenics. FNJ has written two books for commercial publication and has a personal belief that good diet quality is important for mental and brain health. MH has received research support from the A2 Milk Company. WM has previously received funding from the Cancer Council Queensland and university grants/fellowships from La Trobe University, Deakin University, University of Queensland, and Bond University, received industry funding and has attended events funded by Cobram Estate Pty. Ltd, received travel funding from Nutrition Society of Australia, received consultancy funding from Nutrition Research Australia, and has received speakers honoraria from The Cancer Council Queensland and the Princess Alexandra Research Foundation. MLC has received Grant/research support from NHMRC, Deakin University School of Health and Social Development, Deakin Health Economics, Institute for Health Transformation, icare Foundation, Medical Research Future Fund, Victorian medical research accelerator fund, beyondblue, Barwon Child, Youth & Family, and Medibank Health Research Fund. HM has received funding from the NHMRC National Institute for Dementia Research, Dementia Australia, and Australian Research Council (ARC). LMY has previously received research funding from H&H Group. MB has received Grant/Research Support from the NIH, Cooperative Research Centre, Simons Autism Foundation, Cancer Council of Victoria, Stanley Medical Research Foundation, Medical Benefits Fund, National Health and Medical Research Council, Medical Research Futures Fund, Beyond Blue, Rotary Health, A2 milk company, Meat and Livestock Board, Woolworths, Avant and the Harry Windsor Foundation, has been a speaker for Abbot, Astra Zeneca, Janssen and Janssen, Lundbeck and Merck and served as a consultant to Allergan, Astra Zeneca, Bioadvantex, Bionomics, Collaborative Medicinal Development, Janssen and Janssen, Lundbeck Merck, Pfizer and Servier. TR has been supported by the Fernwood Foundation. TR has received grants, fellowships and research support from University of the Sunshine Coast, Australian Postgraduate Awards, Fernwood Foundation and Be Fit Food. TR received consultancy, honoraria and travel funds from Oxford University Press, the University of Melbourne, the University of Sydney, Bond University, University of Southern Queensland, Dietitians Association of Australia, Nutrition Society of Australia, The Royal Australian and New Zealand College of Psychiatrists, Academy of Nutrition and Dietetics, Black Dog Institute, Australian Rotary Health, Australian Disease Management Association, Department of Health and Human Services, Primary Health Networks, Barwon Health, West Gippsland Healthcare Group, Central West Gippsland Primary Care Partnership, Parkdale College, City of Greater Geelong and Global Age. AR has previously been supported by Postdoctoral Fellowship from Faculty of Health, Deakin University. MM has received Grant/research support from NHMRC, Deakin University School of Medicine, Deakin Biostatistics Unit, Institute for Mental and Physical Health and Clinical Translation, and Medibank Health Research Fund. AO has received research funding from National Health & Medical Research Council, Australian Research Council, University of Melbourne, Deakin University, Sanofi, Meat and Livestock Australia and Woolworths Limited and Honoraria from Novartis.
Funding Information:
We would like to acknowledge the work of Catherine Helson in the early development of this trial. We would also like to thank Jessica Batti and Melissa Lane for their assistance with data collection. The authors thank Professor Graham Giles of the Cancer Epidemiology Centre of The Cancer Council Victoria, for permission to use the Dietary Questionnaire for Epidemiological Studies (Version 2), Melbourne: The Cancer Council Victoria 1996.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Beta-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. Discussion: This 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 registration: The trial protocol has been prospectively registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12618002023235. Registered on 17 December 2018.
AB - Background: Beta-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. Discussion: This 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 registration: The trial protocol has been prospectively registered with the Australia and New Zealand Clinical Trials Registry, ACTRN12618002023235. Registered on 17 December 2018.
UR - http://www.scopus.com/inward/record.url?scp=85121041501&partnerID=8YFLogxK
U2 - 10.1186/s13063-021-05812-6
DO - 10.1186/s13063-021-05812-6
M3 - Article
C2 - 34895297
AN - SCOPUS:85121041501
SN - 1745-6215
VL - 22
JO - Trials
JF - Trials
IS - 1
M1 - 899
ER -
