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

Funding

University,Deakin University

Scientific enquiries

Prof Felice N Jacka

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 biomarker .... 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.
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Key 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 int .... 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.
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Key Exclusion Criteria

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 .... 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 disease, hemi colectomy, ileostomy, and colostomy). Regular use of: morphine/opioid-based medications, recreational/illicit drugs, Antibiotic use within 1 month prior to baseline.
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