Investigating the Effects of Dairy Phospholipids on Sleep and Daytime Function in Healthy Adults.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-49
SponsorNorthumbria University
About this trial
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.
Eligibility criteria
Qualifiers
Participants must self-assess themselves as being in good health.
Participants must be aged 25 to 49 years at the time of giving consent.
Participants must be a native speaker of English or fluent in English
Disqualifiers
Have any pre-existing medical conditions/illness which will impact taking part in the study. There may be other, unforeseen exceptions and these will be considered on a case-by-case basis: i.e., participants may be allowed to progress to screening if they have a condition/illness which would not interact with the active treatments or impede performance. It is therefore worth discussing any medical conditions with the researcher prior to booking appointments
Are currently taking any prescription medications (NOTE the explicit exceptions to this are contraceptive treatments for female participants, and those taking "as needed" in the treatment of asthma and/or hay fever. There may be other instances of medication use which, where no interaction with the active treatment is likely, and which would not be expected to have any impact on brain function, participants may be able to progress to screening
Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg). NOTE: that we must measure this in the lab using our blood pressure monitors and can only use our measurements to assess eligibility rather than home or GP readings
Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2.
Trial design
Treatments tested in this trial
- Active
- Placebo
Treatment groups
70 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov