A randomized controlled trial investigating the neurocognitive effects of Lacprodan® PL-20, a phospholipid-rich milk protein concentrate, in elderly participants with age-associated memory impairment: The Phospholipid Intervention for Cognitive Ageing Reversal (PLICAR): Study protocol for a randomized controlled trial
Creators: name: Scholey, Andrew
name: Camfield, David
name: Hughes, Matthew
name: Woods, Will
name: Stough, Con
name: White, David
name: Gondalia, Shakuntla
name: Frederiksen, Pernille D.
Publisher: name: Swinburne
Year: 2024
Subjects: classificationCode: 520201
subject: Behavioural genetics
classificationCode: 520202
subject: Behavioural neuroscience
classificationCode: 520203
subject: Cognitive neuroscience
classificationCode: 520205
subject: Psychopharmacology
classificationCode: 520206
subject: Psychophysiology
classificationCode: 520207
subject: Social and affective neuroscience
classificationCode: 520301
subject: Clinical neuropsychology
classificationCode: 520401
subject: Cognition
classificationCode: 520403
subject: Learning, motivation and emotion

description: Background: Age-related cognitive decline (ARCD) is of major societal concern in an ageing population, with the development of dietary supplements providing a promising avenue for amelioration of associated deficits. Despite initial interest in the use of phospholipids (PLs) for ARCD, in recent years there has been a hiatus in such research. Because of safety concerns regarding PLs derived from bovine cortex, and the equivocal efficacy of soybean-derived PLs, there is an important need for the development of new PL alternatives. Phospholipids derived from milk proteins represent one potential candidate treatment. Methods: In order to reduce the effects of age-associated memory impairment (AAMI) the Phospholipid Intervention for Cognitive Ageing Reversal (PLICAR) was developed to test the efficacy of a milk protein concentrate rich in natural, non-synthetic milk phospholipids (Lacprodan® PL-20). PLICAR is a randomized, double-blind, placebo-controlled parallel-groups study where 150 (N=50/group) AAMI participants aged&gt;55years will be randomized to receive a daily supplement of Lacprodan® PL-20 or one of two placebos (phospholipid-free milk protein concentrate or inert rice starch) over a 6-month (180-day) period. Participants will undergo testing at baseline, 90days and 180days. The primary outcome is a composite memory score from the Rey Auditory Verbal Learning Test. Secondary outcomes include cognitive (verbal learning, working memory, prospective and retrospective memory, processing speed and attention), mood (depression, anxiety, stress and visual analogue scales), cardiovascular (blood pressure, blood velocity and pulse wave pressure), gastrointestinal microbiota and biochemical measures (oxidative stress, inflammation, B vitamins and Homocysteine, glucoregulation and serum choline). Allelic differences in the Apolipoprotein E and (APOE) and Methylenetetrahydrofolate reductase (MTHFR) gene will be included for subgroup analysis. A subset (N=60; 20/group)) will undergo neuroimaging using functional magnetic resonance imaging (fMRI) and magnetoencephalography (MEG) in order to further explore in vivo central mechanisms of action of Lacprodan® PL-20. This study will enable evaluation of the efficacy of milk-derived phospholipids for AAMI, and their mechanisms of action. Trial registration: The trial is jointly funded by Arla Foods and Swinburne University of Technology, currently recruiting and is registered on the Australian New Zealand Clinical Trials Registry as ACTRN12613000347763.