None listed
Conditions
Brief summary
The aim of the present study is to investigate the effects of Complex Milk Lipids on cognitive function and other health-related outcomes—including physical health, psychological wellbeing and blood biomarkers—in ageing adults 55-to-75 years of age. Ingredients developed by the principal trial sponsor contain higher levels of milk phospholipids and gangliosides (complex lipids) and may have the potential to produce benefits on these outcomes. This will be a 16-week randomised, double-blind placebo-controlled trial where 300 participants will be recruited across the CSIRO and Swinburne University sites. The trial will consist of three intervention arms: 1) Low dose milk drink delivering ~10g of total CMLs; 2) High dose milk drink delivering 25g of total CMLs; and 3) Rice starch placebo control
Interventions
Arm 1: Low dose Complex Milk Lipids (CML)
Participants will be required to consume 2 x 25g serves of milk powder per day. Each serve is to be mixed with around 200ml water and can be consumed in two sittings or in a single sitting. Each daily dose contains roughly 10g of total CMLs. Participants consume the milk drink daily for 112 days. There are no specific requirements as to when participants consume their regular food relative to consumption of the milk drink.
Arm 2: High dose Complex Milk
Arm 1: Low dose Complex Milk Lipids (CML) Participants will be required to consume 2 x 25g serves of milk powder per day. Each serve is to be mixed with around 200ml water and can be consumed in two sittings or in a single sitting. Each daily dose contains roughly 10g of total CMLs. Participants consume the milk drink daily for 112 days. There are no specific requirements as to when participants consume their regular food relative to consumption of the milk drink. Arm 2: High dose Complex Milk Lipids (CML) Identical to Arm 1 except each daily dose contains roughly 25g of total CMLs. Compliance will be monitored throughout the study. Participants will receive regular SMS/emails to monitor compliance including the number of intervention product serves missed in the preceding days. Participants will be assisted with this process through the completion of a consumption calendar that requires them to mark off each serving at time of its consumption. Participants who consume less than 80% of the required product in a given fortnight (equal to 6-or-more serves missed) will receive a courtesy call from the trial coordinator to problem solve compliance issues.
Sponsors
Fonterra
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
55 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males and females 2. Aged >55 & <76 years of age at clinic screen 3. Scores >25 on the subjective memory complaints questionnaire (MAC-Q) 4. BMI >18.5 or <35 at time of clinic screen 5. No Depression (indicated by scores <6 on the Geriatric Depression Scale (GDS-15)
Exclusion criteria
1. Score of <22 on the MoCA 2. Previous adverse reaction to milk or dairy proteins 3. Allergy to rice 4. Any condition/event* where cognitive impairment may occur as determined by the PI (e.g., head injury, other brain trauma, transient ischemic attacks, stroke, coronary artery bypass surgery, heart surgery, degenerative neurological disease) 5. Previous diagnosis of Sleep Apnoea that remains untreated 6. Blood pressure >155 mmHg and diastolic >95 mmHg (unless applicant obtains letter from medical professional indicating fit for inclusion) 7. HbA1c >6.5% for non diabetics (=48mmol/mol), OR =7% (=53mmol/mol) if diagnosed with T2D and medically managed for at least 6-months 8. Type 1 Diabetes 9. Current smoker (or history of smoking including within last 12 months) 10. History of Intellectual Disability or other neurodevelopmental disorder (e.g., language disorder, ADHD, Autism)* 11. A mental health condition* that is being actively treated either pharmacologically or by a licensed mental-health professional 12. Participation in a study utilising the primary cognitive measures within the previous 12 months 13. Current or recent participation, within the last 30 days, in any other clinical trial involving the administration of an active intervention for any purpose. * confirmed by trained Clinic Team Member; no clinical testing will be conducted to diagnose/confirm medical history
Outcome results
None listed