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

NCT06780774 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-10

No results posted yet for this study

Summary

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.

Conditions

  • Caffeine
  • Sleep
  • Cognitive Function
  • Wellbeing
  • Mood

Interventions

DIETARY_SUPPLEMENT

Caffeine, Vitamins, Minerals and Botanical Blend

Blend containing 120mg of caffeine, vitamins, minerals and botanical extracts in capsule form. Other Names: Active Treatment

DIETARY_SUPPLEMENT

Placebo

Blend containing 17mg Marigold Extract and Brown rice flour. Other Names: Placebo Treatment

Sponsors & Collaborators

  • Northumbria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-24
Primary Completion
2025-12-19
Completion
2025-12-19

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06780774 on ClinicalTrials.gov