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 | Not Yet Recruiting

• 1 other identifier: 67G1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Caffeine; Cognitive function; Sleep; Wellbeing; Mood

Outcome Measures

Primary Outcomes (1)

• 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.

  Prior to (acute) and following 29-day chronic supplementation

Secondary Outcomes (17)

• Working Memory - Cognitive domain factor score

  Prior to (acute) and following 29-day chronic supplementation

• Episodic Memory - Cognitive domain factor score

  Prior to (acute) and following 29-day chronic supplementation

• Executive Function - Cognitive Domain factor score

  Prior to (acute) and following 29-day chronic supplementation

• Choice Reaction Time

  Days 7, 14 and 21, for both study arms

• Numeric Working Memory

  Days 7, 14 and 21, for both study arms

Study Arms (2)

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).

Dietary Supplement: Caffeine, Vitamins, Minerals and Botanical Blend

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).

Dietary Supplement: Placebo

Interventions

Caffeine, Vitamins, Minerals and Botanical Blend DIETARY_SUPPLEMENT

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

Caffeine, Vitamins, Minerals and Botanical Blend (Capsule)

Placebo DIETARY_SUPPLEMENT

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

Placebo (Capsule)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Have a Body Mass Index (BMI) outside of the range 18.5-39.9 kg/m2.
• Are pregnant, seeking to become pregnant or lactating.
• Have been diagnosed with a neurological condition or assessed as having a learning/behavioural or neurodevelopmental difference (e.g. dyslexia, autism, ADHD).
• Have a visual impairment that cannot be corrected with glasses or contact lenses (including colour-blindness).
• Smoke tobacco/ vape nicotine/ 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).
• Have relevant food allergies/ intolerances/ sensitivities (Please discuss all allergies/ intolerances/ sensitivities with the researcher prior to your screening appointment).
• Have taken antibiotics within the past 4 weeks.
• 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).
• 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).
• 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).
• Are currently participating in another clinical or nutrition intervention study or have done so in the past 4 weeks.

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Brain Performance and Nutrition Research Centre- Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE1 8SG, United Kingdom

Location

MeSH Terms

Interventions

Caffeine; Vitamins; Minerals

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Inorganic Chemicals

Central Study Contacts

Emma L Wightman, PhD

CONTACT

0191 243 7253; emma.l.wightman@northumbria.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Treatment will be blinded according to the randomisation schedule by a researcher who has no other involvement in the study.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, double-blind, placebo-controlled, crossover design.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 24, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: February 10, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Immediately following publication with no end date.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, such as for the purpose of a meta-analysis. Any named author on this project/publication will be able to approve and provide access to the IPD.

Locations

GB (1)