Investigating the Acute and Chronic Effects of a Supplement Containing Caffeine, Vitamins, Minerals and Botanical Extracts on Cognition, Sleep and Wellbeing, in Healthy Volunteers

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.

NCT Number	NCT06780774
Lead Sponsor	Northumbria University
Conditions	Caffeine, Sleep, Cognitive Function, Wellbeing, Mood
Enrollment	90 participants
Start Date	2025-02-24
Primary Completion	2025-12-19 (estimated)
Study Completion	2025-12-19 (estimated)
Updated on ClinicalTrials.gov	2025-02-10