An interventional study of Active and Placebo in Sleep, Morning Alertness and Evening Alertness, sponsored by Northumbria University. Not yet recruiting. Open to participants aged 25 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.
Sponsored by Northumbria University · Not applicable, Interventional, and Other
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.
The study will follow a randomised, placebo-controlled, double-blind, parallel groups design. Participants will be given 12-weeks; worth of either placebo or active treatment to be consumed at home each day (double blinded), will attend all 7 appointments required at the research centre, will complete the at home treatment diary daily, as well as completing the at home tasks.
Participants will attend the research centre on six separate occasions, which will include a screening/training visit, pre intervention testing visit, a mid-point testing visit (at 6 weeks), a completion of intervention testing visit (at 12 weeks), as well as 2 collection visits to retrieve equipment for the at home tasks. 7 Appointments in total including the online appointment to check for eligibility. The remote screening session will be completed via telephone call and will comprise briefing on the requirements for the study, answering any initial questions, obtaining of informed consent via completion of an online consent form, health screening, collection of demographic information, and completion of the Caffeine Consumption Questionnaire (CCQ).
The introductory/training visit to the laboratory will begin with physiological eligibility measures that cannot be completed remotely (e.g., blood pressure, height and weight, waist-to-hip ratio) followed by training on the cognitive and mood measures. Instructions on the at home tasks will also be given here including how to provide saliva samples, how to access and use Cognimapp (at home cognitive assessment tool), and how to use the actigraphy sleep watches.
The study will include 70 healthy participants aged between 25-49 years, who will receive 12 weeks; worth of either 40g per day of bioactive whey protein concentrate powder containing dairy phospholipids (to be mixed with 350ml of water to form a drink), or a similar of placebo powder. Participants will be randomly allocated to either the treatment or placebo group and neither the participant nor the researcher will know which group they have been allocated to. Full instructions of how and when to take treatment each day will be explained to the participants when treatment is given at testing visit 1.
On each of the three study days (Day 1, 42, and 84) participants will attend the research centre, having abstained from alcohol for 24 hours, and caffeine overnight, following a standardised breakfast of cereal and/or toast at home no later than 1 hour prior to arrival. After completing the cognition tasks outlined in a separate protocol, The participants will be administered their treatment and instructed on/reminded of how it should be taken each day (Day 1 and 42). Participants will be asked to return any unused treatment at visit 2 and 3, along with their treatment diary. Participants will additionally complete a treatment guess form at their final visit and will be fully debriefed.
Participants will need to attend the research centre 7 days prior to each of the testing visits (this will be the training visit in the case of Day 1 testing visit), to retrieve their at home testing equipment. This will include an actigraphy sleep watch, a saliva sampling kit, and instructions on how to provide a saliva sample, how to use the actigraphy sleep watches, and how to access the online cognitive assessments. They will also be provided with a sleep diary.
Participants will wear the sleep watches for 7 days prior to each of the 3 testing visits. They will also complete a sleep diary for this duration. In addition, participants will provide saliva samples at 4 different time points (wakening, 30 minutes post wake, 45 minutes post wake, before bed) for 3 consecutive days before each testing visit. Finally, participants will also complete several cognitive tasks for 3 consecutive mornings and evenings before each testing visit. They will access the cognitive tasks through a online software (Cognimapp) that allows participants to complete cognitive assessments from home. The assessments will be measures of morning and evening alertness and will also include a alertness visual analogue scale.
As outlined in another protocol, participants will also be completing a battery of questionnaires the day before the testing visits. Within this battery of questionnaires, they will also complete a dream questionnaire.
Northumbria University is the lead sponsor of 156 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
40g pre weighed powder to be mixed with 350ml of water. Consumed one daily for 12 weeks alongside their fattiest meal of the day.
Dietary Supplement: Active
Placebo powder matched for macro-nutrient and caloric content containing pea protein around 40g powder mixed with 350ml of water consumed once daily for 12 weeks alongside fattiest meal of the day.
Dietary Supplement: Placebo
40g bio-active whey protein concentrate powder containing dairy phospholipids Other Names: Active Treatment
Around 40g pea protein powder not containing dairy phospholipids Other Names: Placebo Treatment
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.
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: prior to (baseline) and following 6- and 12-week chronic intervention
Cognitive and somatic 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 27 item measure related to cognitive and somatic anxiety. 4-point scale with the following options; "Not at all", "Somewhat", "Moderately", and "Very much".
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Anticipated and Experienced Demand 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 5 item scale completed morning and evening to measure anticipated (morning) versus experienced (evening) demand of the day.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Perceived Stress via the Perceived Stress Scale:
10-item measure, summed to create a single value with higher scores indicating higher levels of stress.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Depression, Anxiety and Stress Scale (DASS-21)
21 item measure, summed to create 3 component scores; depression, anxiety, and stress.
Time frame: Prior to (baseline) and following 6- and 12-week chronic intervention
Fatigue Assessment Scale (FAS)
10-item measure, summed to create a measure of over perceived fatigue.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Perceived Stress Reactivity Scale (PSRS)
23-item measure, summed to create measures of prolonged reactivity, reactivity to work overload, reactivity to social conflict, reactivity to failure, reactivity to social evaluation, and perceived stress reactivity.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
The Cohen-Hoberman Inventory of Physical Symptoms (CHIPS)
33-item measure, summed to create a measure of number of health complaints in the previous 2 weeks.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Self-reported morning alertness via visual analogue scale (VAS)
Digital visual analogue scale completed each morning for 3 consecutive days at each of the 3 time points (baseline, following 6-, and 12- week supplementation). 21x100mm line anchored at either end by "Alter" and "inattentive".
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Self-reported evening alertness via visual analogue scale (VAS)
Digital visual analogue scale completed each evening for 3 consecutive days at each of the 3 time points (baseline, following 6-, and 12- week supplementation). 21x100mm line anchored at either end by "Alter" and "inattentive".
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Diurnal cortisol measured through saliva sampling
Diurnal cortisol levels measured via morning (X3) and evening (X1) saliva samples for three consecutive days at each time point (baseline, following -6 and 12- week supplementation).
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Subjective sleep via the Patient-Reported Outcome Measurement, Information System Sleep Disturbance Scale- short form (PROMIS-SD)
8-item measure, summed to create a single value with higher scores indicating higher levels of sleep disturbances.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective morning alertness via the Choice Reaction Time (CRT) task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive mornings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Includes 50 stimuli and scored for percentage of correct responses and reaction time (msec).
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective morning alertness via the Digit Vigilance (DV) task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive mornings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Outcomes include accuracy, mean reaction time and number of false alarms.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective morning alertness via the Peg and Ball task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive mornings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Task outcomes include average thinking time, completion time and errors.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective Evening alertness via the Choice Reaction Time (CRT) task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive evenings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Includes 50 stimuli and scored for percentage of correct responses and reaction time (msec).
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective evening alertness via the Digit Vigilance (DV) task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive evenings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Outcomes include accuracy, mean reaction time and number of false alarms.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Objective evening alertness via the Peg and Ball task
Cognition task completed on smartphones via an online cognition website "cognimapp" sent to participant via a link from the researcher for 3 consecutive evenings at each of the 3 time points (baseline, following 6-, and 12- week supplementation). Task outcomes include average thinking time, completion time and errors.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
Exploratory outcome: Changes to dream recall
Measurement of multiple aspects of dreaming including frequency, type, intensity, and attitudes/emotions towards dreams. Measured at 3 time points; baseline, following 6 weeks supplementation, and following 12 week supplementation.
Time frame: prior to (baseline) and following 6- and 12-week chronic intervention
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Plan to share: No
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Northumbria University