About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Caffeine, Vitamins, Minerals and Botanical Blend
- Placebo