None listed
Conditions
Brief summary
In order to reduce the effects of age-associated memory impairment (AAMI) the Phospholipid Intervention for Cognitive Ageing Reversal (PLICAR) was developed so as to test the efficacy of a milk protein concentrate rich in phospholipids (Lacprodan(Registered Trademark) PL-20) for the improvement of cognitive function in elderly individuals with AAMI. ). On the basis of previous human clinical studies with bovine and plant-derived phospholipids, it is hypothesised that Lacprodan(Registered Trademark) PL-20 supplementation over 180 days will result in significant improvements to memory and other cognitive functions.
Interventions
Lacprodan(Registered Trademark) PL-20 is a fat-reduced cream powder manufactured by Arla Foods Ingredients P/S, Denmark. In comparison to regular cream powder Lacprodan(Registered Trademark) PL-20 is enriched in protein and phospholipids, while its triglyceride and lactose content is reduced.
Lacprodan(Registered Trademark) PL-20 will be administered orally at a maximum dose of 16g/day, providing minimum daily dosages of 2.7g total phospholipids and 300mg phosphatidylserine (PS). Lacprodan wi
Lacprodan(Registered Trademark) PL-20 is a fat-reduced cream powder manufactured by Arla Foods Ingredients P/S, Denmark. In comparison to regular cream powder Lacprodan(Registered Trademark) PL-20 is enriched in protein and phospholipids, while its triglyceride and lactose content is reduced. Lacprodan(Registered Trademark) PL-20 will be administered orally at a maximum dose of 16g/day, providing minimum daily dosages of 2.7g total phospholipids and 300mg phosphatidylserine (PS). Lacprodan will be administered as a powder dissolved in <=250mL water and drunk once per day with breakfast for 180 days (6 moinths). The Phospholipid composition of Lacprodan(Registered Trademark) PL-20 is as follows: (Percentages(%) and minimum dosages per 16g) Shingomyelin 4.3% 688 mg Phosphatidyl choline (PC) 4.3% 688 mg Phosphatidyl serine (PS) 1.9% 304 mg Phosphatidyl ethanolamine (PE) 3.5% 560 mg Phosphatidyl inositol (PI) 1.3% 208 mg Gangliosides and others 0.7% 112 mg Treatment compliance will be monitored by the use of a compliance log which participants will take home with them and record the time at which they consume the drinks every day. If for some reason they miss a dose, they will be instructed to make a note of this in the log. In addition to the compliance log, participants will also be required to return all unused sachets at the completion of the study so that the experimenter can confirm that the number of sachets they have taken is in agreement with their log.
Sponsors
Swinburne University of Technology
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
56 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Male or female. -Aged >55 years. -Meets diagnostic criteria for age-associated memory impairment: AAMI is defined on the basis of criteria first outlined by Crook et al: (i) A score >25 on the Memory Complaint Questionnaire (MAC-Q) and (ii) a score at =1 standard deviation below the mean for healthy young adults on the Paired Associates Test from the Wechsler Memory Scale - Revised (WMS-R) -Willing and able to provide written informed consent. -Understands and is willing and able to comply with all study procedures. -English speaking. -Normal or corrected vision. -Must be right-handed (applies only to the neuroimaging sub-study).
Exclusion criteria
Dementia and/or MMSE score <24. Neurological, cardiac, endocrine, gastrointestinal or bleeding disorders. Psychiatric illness including mood disturbance/depression, as confirmed with a BDI-II >=20. History of alcoholism and/or substance abuse. Any known or suspected allergy to cow’s milk and/or lactose intolerance. Smoker. Participation in another clinical trial during the past 2 months. Using any medications that could affect the outcome of the study including any pharmacological agents with known cognitive effects and diabetic medications. Taking vitamins or herbal supplements regularly.
Outcome results
None listed