Investigating the Effects of Dairy Phospholipids on Sleep and Daytime Function in Healthy Adults.

The aim of the study is to investigate the effects of 6- and 12- week supplementation of a bioactive whey protein concentrate drink containing dairy phospholipids on sleep and daytime function parameters in healthy adults. The proposed randomised, double-blind, placebo-controlled parallel groups design methodology will assess the sleep and daytime function effects (both self-reported and physiological) of 40g per day of bioactive whey protein concentrate in the form of a powder that the participant will be required to mix with 350ml of water and matched placebo prior to (baseline) and after -6 week and -12 week supplementation. The trial will utilise actigraphy sleep watches and online cognitive assessments alongside saliva sampling, sleep diaries, and self-report questionnaires as measures of the outcome variables. 70 participants will participate, aged 25-49, and self-reported as being in good health. Participants will be supplied with either the active treatment or the placebo (allocated by a randomised schedule) whilst visiting the research centre for the testing appointments and will take treatment home to consume daily for the duration of the study. Participants will record time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, upon completion of the study.

NCT Number	NCT06663865
Lead Sponsor	Northumbria University
Conditions	Sleep, Morning Alertness, Evening Alertness, Diurnal Cortisol
Enrollment	70 participants
Start Date	2024-10-28
Primary Completion	2025-06-27 (estimated)
Study Completion	2025-06-27 (estimated)
Updated on ClinicalTrials.gov	2024-10-29