None listed
Conditions
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.
Interventions
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
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 weeks, all participants are to consume at least 250ml of the study milk and the study cheese ad libitum. The study products will be nutritionally equivalent with the exception of beta-casein content. Conventional dairy products will contain both A1 and A2 beta-casein protein whereas A2 dairy products will contain only A2 beta-casein. Participants are to refrain from consuming all other cow’s milk products throughout the intervention, with the exception of goat and sheep’s yoghurt. Dairy diaries will be provided to participants to facilitate the completion of fortnightly online questionnaires, which will be used to monitor dietary adherence. The intervention will be delivered by investigators with expertise in food science, and casual research assistants who will be employed as required. Individual study assessments will take place in clinic at University Hospital Geelong at baseline, week 4 and week 16. At baseline (part A), participants will complete a series of online questionnaires online with a researcher and be mailed out a stool collection kit. Within one week of baseline (part A), the participant will visit the clinic (part B) to return their collected stool sample, provide a blood sample and undergo a cognitive assessment. Participants will receive instructions regarding their dietary prescription and receive their allocated dairy products. At week 4 (approx. 20 minutes), participants will meet with study investigators to return completed stool samples, provide a blood sample and collect additional dairy products. At week 16 (approx. 2 hours), participants will return completed stool samples, complete a series of questionnaires, provide a blood sample and undergo a cognitive assessment and body composition scan. If required, participants will also attend the clinic at week 10 to collect additional dairy products. At fortnightly intervals throughout the intervention, participants will complete a series of online questionnaires at home pertaining to primary and secondary outcomes of this study.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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 disease, hemi colectomy, ileostomy, and colostomy). Regular use of: morphine/opioid-based medications, recreational/illicit drugs, Antibiotic use within 1 month prior to baseline.
Outcome results
None listed