Data

The Moo'D Study: A randomised controlled trial of A2 vs conventional dairy products in women with low mood.

Deakin University

Dataset description

This trial evaluated 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. ‘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, were measured by the 21-item Depression, Anxiety and Stress Scale. Secondary outcomes 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.
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Related Study

The Moo'D Study: A randomised controlled trial of A2 vs conventional dairy products in women with low mood.

Brief Summary

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 biomarkers of inflammation and oxidative stress. Participants will be randomised to receive either the A2 dairy products (A2 skim milk and full fat cheddar cheese) or conventional dairy products (conventional skim milk and full fat cheddar cheese). Participants are to replace their existing dairy products with the study products and consume at least 250ml of the study milk each day. All other dairy products are to be excluded for the duration of the intervention. Participants will complete in-clinic assessments at week 0,4 and 16 and fortnightly online questionnaires at home. It is hypothesised that 16-week consumption of A2 dairy products will be associated with the reduction of psychological distress in women with low mood at the completion of intervention phase, compared to the consumption of conventional dairy products.

Inclusion Criteria

  • 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 interventional clinical research trial while part of the study.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification.

When will data be available?

Immediately following publication. No end date.

Available to whom?

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

Available for what types of analyses?

Any purpose.