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.
The 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.
The 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.
90 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.
You self-assess yourself as being in good health.
You are aged 18-75 years at the time of giving consent.
English is your first language or are fluent in English.
Insufficient (< 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.).
Have any pre-existing medical conditions/illnesses which will impact taking part in the study. (* NOTE: The explicit exceptions to this are controlled hyper/hypothyroidism, 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/illness 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).
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.).
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.
Crossover
Caffeine, Vitamins, Minerals and Botanical Blend
Dietary supplementBlend containing 120mg of caffeine, vitamins, minerals and botanical extracts in capsule form. Other Names: Active Treatment
Placebo
Dietary supplementBlend containing 17mg Marigold Extract and Brown rice flour. Other Names: Placebo Treatment
Attention - Cognitive domain factor score
Effects of supplementation on the cognitive domain Attention, measured using the following tasks through the Computerised Mental Performance Assessment System (COMPASS, Northumbria University): Choice Reaction Time and Rapid Visual Information Processing. Scores of accuracies will be in the form of the percentage of responses correct and scores of performance speed will be reaction time measured in milliseconds, with lower scores indicating faster response time.
Working Memory - Cognitive domain factor score
Effects of supplementation on the cognitive domain Working Memory, measured using the following tasks through the Computerised Mental Performance Assessment System (COMPASS, Northumbria University): Numeric Working Memory (NWM), Serial 3s subtractions, Serial 7 subtractions and Corsi Blocks. Scores of accuracies will be in the form of the percentage of responses correct. For Numeric Working Memory task, scores of performance speed will be reaction time measured in milliseconds, with lower scores indicating faster response time.
Episodic Memory - Cognitive domain factor score
Effects of supplementation on the cognitive domain Episodic Memory, measured using the following tasks through the Computerised Mental Performance Assessment System (COMPASS, Northumbria University): Immediate Word Recall, Delayed Word Recall, Delayed Name to Face Recall, Delayed Picture Recognition and Delayed Word Recognition. Scores of accuracies will be in the form of the percentage of responses correct. For the following tasks, scores of performance speed will be reaction time measured in milliseconds, with lower scores indicating faster response time: Delayed Name to Face Recall, Delayed Picture Recognition and Delayed Word Recognition.
Executive Function - Cognitive Domain factor score
Effects of supplementation on the cognitive domain Executive Function, measured using the following tasks through the Computerised Mental Performance Assessment System (COMPASS, Northumbria University): Peg and Ball, and Cognitive Demand Battery (comprised of 3 repetitions of Serial 3s subtractions, Serial 7s subtractions and Rapid Visual Information Processing tasks). For Peg and Ball, scores will include average thinking time and completion time in milliseconds, with lower scores indicating faster response time, along with number of errors.
Choice Reaction Time
Cognition task completed on smartphones via an online cognition website "Cognimapp" sent to participants via a link from the researcher at days 7, 14 and 21 of the supplementation periods. Performance on Choice Reaction Time task - accuracy and reaction time outcomes Cognitive task score, % and msecs.
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