The Moo'D Study
ACTRN12618002023235
Treatment
Not Applicable
University,Deakin University
Prof Felice N Jacka
The aim of this present randomised controlled trial is to assess the possible effects of 16-week consumption of A2 dairy products, versus conventional dairy products, on symptoms of psychological distress in 90 women with low mood. Secondary aims of this study are to assess possible effects from consumption of these two dairy products on symptoms of depression, anxiety and stress; gut symptoms; gut microbiota; body composition; cognition; well-being; health-related quality of life; and biomarker .... Read more
Female participants with low mood as determined by a PHQ-8 score of 5 or higher at baseline. Current conventional milk consumption of at least 250ml/day. Willingness to commit to consuming only dairy products provided by the study. Available for intervention duration. Able to understand study materials and directions, in English. Must have access to internet and a computer/smartphone/tablet. Be willing to comply with all requirements and procedures of the study. Agree not to enrol in another int .... Read more
Current consumer of A2 dairy products. Cow’s milk (dairy) allergy (established diagnosis). Lactose intolerance (established diagnosis). Pregnant, planning to become pregnant, or lactating. History of dementia and/or stroke. Diagnosed with or commenced new treatment for, anxiety and/or depression, within 1 month prior to baseline. Gastrointestinal (GI) diseases or past major GI surgery likely to interfere with study outcomes (e.g. ulcerative colitis, crohn's disease, faecal impaction, coeliac dis .... Read more
No
Sample Size 74
Min. age 18 Years
Max. age 75 Years
Sex Females
Condition category Psychological distress
Condition code Mental Health
Intervention code Lifestyle , Treatment: Other
This is a triple-blinded, 16-week, 1:1 parallel-group, randomised controlled trial. Women aged 18-75 years with low mood will be randomised to receive either A2 dairy products (A2 skim milk + A2 full fat cheddar cheese) or conventional dairy products (conventional skim milk + conventional full fat cheddar cheese). Participants will be provided with all study products, supplied by The a2 Milk Company, which are to replace usual amounts of dairy products consumed within the diet. Each day for 16 w .... Read more
Control group Active
Participants allocated to the control group will consume conventional dairy products (conventional skim milk + conventional full fat cheese) in amounts prescribed above. Control products will also be supplied by The a2 Milk Company. Control participants will complete the assessment schedule, as per the intervention group.
Outcome: Symptoms of psychological distress (depression, anxiety and stress) as measured by the Depression Anxiety Stress Scale-21 (DASS- 21) total score.Timepoint: Baseline (week 0) and every two weeks after that (weeks 2, 4, 6, 8, 10, 12, 14, 16).
yes
All of the individual participant data collected during the trial, after de-identification.
Immediately following publication. No end date.
Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.
Any purpose.