[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576091":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":86,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Northumbria University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Caffeine, Vitamins, Minerals and Botanical Blend (Capsule)","EXPERIMENTAL","Blend containing 120mg of caffeine, vitamins, minerals and botanical extracts in capsule form. The treatment will be consumed daily, for 29 days, as one bolus dose (2 capsules).",[13],"Dietary Supplement: Caffeine, Vitamins, Minerals and Botanical Blend",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Capsule)","PLACEBO_COMPARATOR","Blend containing 17mg Marigold Extract and Brown rice flour, in capsule form. The treatment will be consumed daily, for 29 days, as one bolus dose (2 capsules).",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Caffeine, Vitamins, Minerals and Botanical Blend","Blend containing 120mg of caffeine, vitamins, minerals and botanical extracts in capsule form.\n\nOther Names: Active Treatment",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Blend containing 17mg Marigold Extract and Brown rice flour. Other Names: Placebo Treatment",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Emma L Wightman, PhD","CONTACT","0191 243 7253","emma.l.wightman@northumbria.ac.uk",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Brain Performance and Nutrition Research Centre- Northumbria University","Newcastle upon Tyne","Tyne and Wear","NE1 8SG","United Kingdom","UK",{"type":46,"coordinates":47},"Point",[48,49],-1.61396,54.97328,{"lat":49,"lon":48},[52,56],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Catherine A Small, MRes","0191 243 7252","a.a.small@northumbria.ac.uk",{"name":33,"role":57,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100576091","investigating-the-acute-and-chronic-effects-of-a-supplement-containing-caffeine-vitamins-minerals-and-botanical-extracts-on-cognition-sleep-and-wellbeing-in-healthy-volunteers-100576091",false,"NCT06780774","Investigating the Acute and Chronic Effects of a Supplement Containing Caffeine, Vitamins, Minerals and Botanical Extracts on Cognition, Sleep and Wellbeing, in Healthy Volunteers","Investigating the Acute and Chronic Effects of a Supplement Containing Caffeine, Vitamins, Minerals and Botanical Extracts on Cognition, Sleep and Wellbeing, in Healthy Volunteers.","Inclusion Criteria:\n\n* You self-assess yourself as being in good health.\n* You are aged 18-75 years at the time of giving consent.\n* English is your first language or are fluent in English.\n\nExclusion Criteria:\n\n* Insufficient (\\\u003C 40 mg per day) or excessive (\\> 500 mg per day) habitual caffeine consumption (\\* NOTE: This will be calculated at screening but feel free to query this with the researcher prior to attendance.).\n* Have any pre-existing medical conditions\u002Fillnesses which will impact taking part in the study. (\\* NOTE: The explicit exceptions to this are controlled hyper\u002Fhypothyroidism, hay fever, high cholesterol and reflux-related conditions. NOTE: 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 so it's worth discussing any medical conditions with the researcher prior to booking lab appointments).\n* Are currently taking prescription medications which will impact taking part in the study (\\* NOTE: the explicit exceptions to this are contraceptive treatments for female participants, thyroid medications, topical skin treatments and those medications used in the treatment of high cholesterol and reflux-related conditions; and those taken 'as needed' in the treatment of asthma and hay fever.).\n* Have high blood pressure (systolic over 139 mm Hg or diastolic over 89 mm Hg1) - \\*NOTE: We must measure this in the lab using our blood pressure monitors and can only use our measurements to access eligibility rather than home or GP readings.\n* Have a Body Mass Index (BMI) outside of the range 18.5-39.9 kg\u002Fm2.\n* Are pregnant, seeking to become pregnant or lactating.\n* Have been diagnosed with a neurological condition or assessed as having a learning\u002Fbehavioural or neurodevelopmental difference (e.g. dyslexia, autism, ADHD).\n* Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness).\n* Smoke tobacco\u002F vape nicotine\u002F use nicotine replacement products (\\* NOTE: If participants have recently quit smoking or using replacements, they must have stopped using them altogether for a period of 3 months before participating in this study).\n* Have relevant food allergies\u002F intolerances\u002F sensitivities (Please discuss all allergies\u002F intolerances\u002F sensitivities with the researcher prior to your screening appointment).\n* Have taken antibiotics within the past 4 weeks.\n* Are currently consuming any other dietary supplement (e.g., vitamins, omega 3 fish oils etc.) or have done so 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 conditions that would prevent the 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 your training appointment, whereby you must be able to reach the minimum scores for each cognitive task to progress with the trial).\n* Are currently participating in another clinical or nutrition intervention study or have done so 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* Suffer from frequent migraines that require medication (more than or equal to 1 per month).\n* Have any sleep disorders or take any sleep aid medications.\n* Have any known active infections.\n* Will be non-compliant with regards to treatment consumption.\n* Does not have a bank account (required for payment).",true,"ALL","18 Years","75 Years",{"count":72,"type":73},90,"ESTIMATED","INTERVENTIONAL",[76],"NA","The aim of the study is to investigate the acute and chronic effects of a supplement containing Caffeine, Vitamins, Minerals and Botanical extracts on cognitive function, sleep and wellbeing, in healthy volunteers.\n\nThe study will follow a randomised, double-blind, placebo-controlled, crossover design. Participants will receive both treatments, and both study arms will include an acute testing visit (day 1) and a chronic testing visit (day 29). The active treatment contains a blend of 120mg caffeine, vitamins, minerals and botanical extracts and the matched placebo treatment contains marigold extract and brown rice flour.\n\nThe trial will use computerised cognitive tasks, administered via COMPASS software (Northumbria University, UK), online cognitive assessments via Cognimapp and self-reported questionnaires and sleep diary, as measures of the outcome variables.\n\n90 participants will participate, aged 18-75, and self-ported as being in good health. Participants will be randomly allocated to a treatment order and will be supplied with either the active treatment or the placebo whilst visiting the research centre for the acute testing visits. Participants will take the treatment home to consume daily for the duration of the supplementation period. Participants will record the time of taking treatment each day in a treatment diary which will be returned to the research centre, along with any unused treatment, at each chronic testing visit.",[79,80,81,82,83],"Caffeine","Sleep","Cognitive Function","Wellbeing","Mood",[79,85,80,82,83],"Cognitive function","NOT_YET_RECRUITING","2025-02-06",{"date":89,"type":90},"2025-02-10","ACTUAL",{"date":92,"type":73},"2025-02-24",{"date":94,"type":73},"2025-12-19",{"name":5,"class":6},1]