The effect of Complex Milk Lipids on cognitive ageing

Not Applicable

Completed

• Conditions: Cognitive function; Psychological wellness; Biochemical Health; Gut function; Physical Health; Mobility; Mental Health - Studies of normal psychology, cognitive function and behaviour; Neurological - Studies of the normal brain and nervous system; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function

• Registration Number: ACTRN12620000270910
• Lead Sponsor: Fonterra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-02
• Study Completion: 2022-06-02
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of this study is to determine whether increased intake of complex milk lipids in older adults exerts beneficial effects on cognitive function as assessed by the Repeatable Battery of Neuropsychological Status (RBANS) [112 days after first dose of study treatment]