None listed
Conditions
Brief summary
A clinical trial to investigate the benefit of a milk ingredient on mental wellbeing, memory and mobility in older women. Over 12 weeks, participants will consume a milk ingredient or a placebo. These will be provided as a powder in a single serve sachet to be taken once per day mixed in a usual beverage, in addition to their usual diet. The supplements will be provided in conjunction with a home-based light exercise and walking programme. We hypothesise that this milk ingredient will be associated with improved physical and mental well-being.
Interventions
This will be a parallel group, double blind randomised controlled trial design. Over 12 weeks, approximately 4g of a milk ingredient will be compared to an energy matched maltodextrin control. Both will be provided as a powder in a single serve sachet to be taken once per day mixed in a usual beverage as a supplement to their usual diet. Compliance/adherence will be monitored by return of sachets. The nutritional intervention will run alongside a home-based light exercise and walking intervent
This will be a parallel group, double blind randomised controlled trial design. Over 12 weeks, approximately 4g of a milk ingredient will be compared to an energy matched maltodextrin control. Both will be provided as a powder in a single serve sachet to be taken once per day mixed in a usual beverage as a supplement to their usual diet. Compliance/adherence will be monitored by return of sachets. The nutritional intervention will run alongside a home-based light exercise and walking intervention. Subjects will visit the Massey University Human Performance Laboratory at baseline and at end of intervention for musculoskeletal function tests and general health status. Stress, coping and memory tests will be assessed at home by relevant online questionnaires at baseline, middle and at end of intervention.
Sponsors
Fonterra Co-operative Group limited
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
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy women aged 65 - 80 years with body mass index (BMI) not less than 20 and not more than 35 kg/m2, and non-athletes with moderate physical activity and stressed as according to a Perceived Stress Scale score of higher than 14.
Exclusion criteria
Smokers, heavy alcohol consumers, use hormone replacement therapy, suffer from chronic diseases (such as Diabetes and chronic kidney disease), mal-absorptive diseases (such as Crohn disease, Ulcerative colitis, and Coeliac), and suffer from Lactose intolerance or allergy to dairy will be excluded. Also, volunteers who are suddenly diagnosed with systemic diseases or mental disorders will be excluded through the follow-up.
Outcome results
None listed