[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"morning-alertness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:morning-alertness":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100567106","investigating-the-effects-of-dairy-phospholipids-on-sleep-and-daytime-function-in-healthy-adults-100567106",false,"NCT06663865","Investigating the Effects of Dairy Phospholipids on Sleep and Daytime Function in Healthy Adults.","Inclusion Criteria:\n\n* Participants must self-assess themselves as being in good health.\n* Participants must be aged 25 to 49 years at the time of giving consent.\n* Participants must be a native speaker of English or fluent in English\n\nExclusion Criteria:\n\n* Have any pre-existing medical conditions\u002Fillness 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\u002Fillness 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\n* 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\u002For 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\n* 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\n* Have a Body Mass Index (BMI) outside of the range 18.5-35 kg\u002Fm2.\n* Are pregnant, seeking to become pregnant or lactating.\n* Have learning and\u002For behavioural difficulties such as dyslexia or ADHD.\n* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness)\n* Smoke tobacco or vape nicotine or use nicotine replacement products (if you have recently quit smoking or using replacements you must have stopped using them altogether for a period of 3 months before participating in this study)\n* Have excessive caffeine intake (500 mg per day). Note: This will be calculated at screening but feel free to query this with the researcher prior to attendance\n* Have relevant food allergies\u002F intolerance\u002F sensitivities\n* Have taken antibiotics within the past 4 weeks.\n* Have taken dietary supplements e.g., vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4 week supplement wash out prior to participating and for the duration of the study on the proviso that the supplements they are taking are out of choice and not medically prescribed or advised. Please discuss with the researcher if unsure. NOTE: we would never advise stopping supplements prescribed by your doctor e.g., iron, calcium etc., only those you use out of choice)\n* Have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)\n* Are unable to complete all of the study assessments (this will be assessed by the researcher at the training appointment)\n* Are currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks\n* Have been diagnosed with\u002F undergoing treatment for alcohol or drug abuse in the last 12 months.\n* Have been diagnosed with\u002F undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.\n* Suffers from frequent migraines that require medication (more than or equal to 1 per month)\n* Have any sleep disorders or take any sleep medications.\n* Routinely work night shifts\n* Have any known active infections.\n* Does not have a bank account (required for payment)\n* Are non-compliant with regards treatment consumption\n* Follow an \"extreme\" or very \"strict\" diet i.e., Keto, very high protein, sugar free, raw paleo etc.\n* Are planning a major lifestyle change regarding diet or exercise regime in the next 3 months.\n* Experienced an event (professional or personal) that is likely to have impacted your emotional and\u002For psychological state within the last 8-10 weeks (for example but not restricted to change of professional function, death of a family member, divorce, surgery, accident etc)\n* Have an upcoming event (personal or professional) that is likely to affect your emotional, psychological state or hormonal state planned during the next 8-10 weeks, including but not limited to job change, house move, important medical exam etc.\n* Have any oral disease such as gingivitis\n* Are planning any overseas travel with significant time zone differences",true,"ALL","25 Years","49 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.\n\nThe 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.\n\n70 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.",[27,28,29,30],"Sleep","Morning Alertness","Evening Alertness","Diurnal Cortisol",[27,32,33,34,35,36],"Daytime function","diurnal cortisol","Morning alertness","Evening alertness","dreams","NOT_YET_RECRUITING","2024-10-28",{"date":40,"type":41},"2024-10-29","ACTUAL",{"date":38,"type":21},{"date":44,"type":21},"2025-06-27",{"name":46,"class":47},"Northumbria University","OTHER"]