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

Launched by NORTHUMBRIA UNIVERSITY · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand how a supplement that contains caffeine, vitamins, minerals, and botanical extracts affects thinking, sleep, and overall wellbeing in healthy adults. The study will involve 90 participants aged 18 to 75 who are in good health and fluent in English. To be eligible, you should not consume too much or too little caffeine daily, and you must not have any medical conditions that would interfere with your ability to participate.

As a participant, you will take either the active supplement or a placebo (which looks the same but doesn’t contain active ingredients) for 29 days. During this time, you will complete tasks on a computer to test your thinking skills and keep a diary about your sleep and how you feel. This study uses a method where neither you nor the researchers will know which treatment you are receiving until the end. It's a great opportunity to contribute to research while learning more about the effects of dietary supplements on health!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.
• • Have been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 12 months.
• • Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 12 months, including a medical diagnosis of anxiety or depression.
• • Suffer from frequent migraines that require medication (more than or equal to 1 per month).
• • Have any sleep disorders or take any sleep aid medications.
• • Have any known active infections.
• • Will be non-compliant with regards to treatment consumption.
• • Does not have a bank account (required for payment).