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

ConditionsSleep Morning Alertness Evening Alertness Diurnal Cortisol

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Active
Dietary supplement
40g bio-active whey protein concentrate powder containing dairy phospholipids Other Names: Active Treatment
Placebo
Dietary supplement
Around 40g pea protein powder not containing dairy phospholipids Other Names: Placebo Treatment

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Bioactive whey protein concentrate containing dairy phospholipidsExperimental treatment 1 intervention

Group B: Placebo PowderPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Sleep quality - Objective sleep quality measured through actigraphy sleep watches

Average scores across 7 days. Scores for sleep onset, total sleep time, wake after sleep onset, awakenings, average awakening, and efficiency of sleep will be averaged

Time frame

prior to (baseline) and following chronic dose of intervention at 6 weeks and 12 weeks.

Secondary outcomes

Acute self-reported state anxiety via the Anticipated Versus Experienced Demand Questionnaire

Completed morning and evening for 3 consecutive days at each time point (baseline, following 6- and 12-week intervention). Self-report 12 item measure related to state anxiety. 4-point scale with the following options; "not at all", "Somewhat", "Moderately", and "Very much".

Time frame