None listed
Conditions
Brief summary
This study is a mixed-methods study, combining an open-label pragmatic parallel group randomised controlled trial (RCT) with qualitative methodology investigating the effect of different milk proteins on brain, immunity, gut and skin health outcomes. There is evidence that different forms of beta-casein proteins, found naturally in milk, have different effects on health. There is also some evidence of an interconnection between the brain, immune, and skin systems linked by the gut microbiome. This study aims to determine the effect of milk containing only a2 beta-casein protein on brain health, immunity and inflammatory markers, gastrointestinal function, and skin health as compared to conventional milk which contains A2 and A1 beta-casein, in healthy older adolescents and adults (16-65 years) in a real world setting. Participants (n=1000) will be randomised to each study arm. The study period goes for 30 days including a 2 day run-in and 28-day intervention. Outcomes will be measured at the start, middle and end of the intervention period. The first 260 participants will be required to have a saliva sample and faecal sample collected pre and post intervention and complete questionnaires at each time point. The remaining 740 participants will complete questionnaires at each time point only. There will additionally be a short (1 min) survey sent twice a week to monitor for adverse events. Participants from the intervention group will be randomly selected and invited to participate in the nested qualitative study (n=30). The study has been planned in accordance with the Declaration of Helsinki, National Health and Medical Research Council National Statement on Ethical Conduct in Human Research. All staff with direct participant contact have completed Good Clinical Practice Guideline training and certification.
Interventions
Participants (n=1000) will be randomised to each study arm. The study period goes for 30 days including: 2 day run-in and 28-day intervention. Outcomes will be measured at the start, middle and end of the intervention period.
The intervention group will consume fresh, full cream (4% fat) cow’s milk, containing A2 ß-casein proteins only. Participants will be asked to consume a minimum of 250mL of milk each day for 28 days, with no maximum amount set. Participants in the intervention group will
Participants (n=1000) will be randomised to each study arm. The study period goes for 30 days including: 2 day run-in and 28-day intervention. Outcomes will be measured at the start, middle and end of the intervention period. The intervention group will consume fresh, full cream (4% fat) cow’s milk, containing A2 ß-casein proteins only. Participants will be asked to consume a minimum of 250mL of milk each day for 28 days, with no maximum amount set. Participants in the intervention group will be asked to avoid conventional cow's milk containing both A1 and A2 ß-casein proteins for the duration of the study and restrict all other dairy to one serving per day, with no other changes to their usual diet, medications, or lifestyle. The first 260 participants enrolled into the study (n=130 intervention group; n=130 control group) will be required to complete (i) two saliva samples, (ii) one faecal sample, and (iii) one cognitive function test called the SCIT test both pre and post intervention at Day 0 and Day 28 (four saliva, two faecal and two cognitive tests in total) and complete questionnaires at each time point (start, middle and end of intervention period). The remaining 740 participants will complete questionnaires at each time point only. Compliance to the protocol will be measured through a survey administered twice a week to record their milk intake, and reconciling milk purchases via receipt upload with reported milk consumption. In addition, participants from the intervention group only who complete the intervention study will be randomly selected and invited to participate in a virtual nested qualitative study. After completing the final study visit, investigators will add each participant’s unique identifier number to a secondary database. Five participant IDs will be randomly selected at weekly intervals using an online randomisation program, and these participants will be invited to participate in the nested qualitative study where they will attend a 1 hour semi-structured interview with researchers via zoom. The semi-structured interviews will be scheduled approximately 1 week post-completion of the 28-day intervention period. IDs will be removed from the database after selection, or after 21 days if not selected. This process will continue until the predetermined sample size has been reached (n=17 - 30 depending on what is required to achieve saturation.
Sponsors
Nutrition Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Humans that live in Australia. Aged 16-65 years inclusive Any sex or gender. BMI: 18.5 to 35kg/m2 inclusive. Can speak and read English. Consume conventional (A1/A2) cow’s milk 5 or more times per week. Agree to maintain current dietary practices, including any medications and supplements, during the study period. Willing to consume at least 250mL cow’s milk every day for 28 days.
Exclusion criteria
- Unable to provide informed consent. - Diagnosed with a chronic disease, including autoimmune conditions, kidney or liver disease, cardiovascular disease, and diabetes. - Diagnosed with one or more of the following mental health conditions: Major depressive disorder, Psychotic disorder such as schizophrenia, Anorexia nervosa, Bulimia nervosa, Substance abuse disorder, Bipolar disorder, Personality disorder. - Currently pregnant or breastfeeding. - Hospitalisation or antibiotic use in the past 4weeks. - Planned change of oral contraception within past 3-months or planned change within the study period. - Currently participating in another biomedical or medical study
Outcome results
None listed