Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue (NCT05530915) | Clinical Trial Compass
CompletedNot Applicable
Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue
United States60 participantsStarted 2022-07-27
Plain-language summary
The primary objective of this randomized, double-blind, placebo-controlled, cross-over study is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive demand battery (CDB) and mood, motivation, and energy measures with assessments taking place at baseline, 60- and 120-minutes post treatment on three separate testing days separated by \~7 days.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female, 18-55 years of age, inclusive at Visit 1 (Day -7).
. BMI \<30 kg/m2 at Visit 1 (Day -7).
. Self-reported poor attention during pre-screening phone call prior to Visit 1 (Day -7).
. Willing to abstain from alcohol and vigorous physical activity 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
. Willing to abstain from all exercise the morning of Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
. Willing and able to comfortably abstain from caffeine for 24 h prior to Visits 1, 2, 3, and 4 (Days -7, 0, 7, and 14).
. Non-user of nicotine products (e.g., cigarettes, patches/gum, etc.) within 60 days of Visit 1 (Day-7).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mental alertness
Timeframe: Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo
. Non-user of marijuana and hemp products including CBD products within 60 days of Visit 1 (Day-7).
Exclusion criteria
. Unable to understand and/or completely perform the practice test to standard minimum requirements and based on queries performed following the practice test at Visit 1 (Day -7).
. Visual impairments that cannot be corrected with glasses or contact lenses.
. Known intolerance, allergy, or sensitivity to caffeine or any of the other ingredients in the study products and/or any ingredients of the standardized snack provided, including shellfish, egg, fish, gluten, milk, peanuts, soy, tree nuts (coconut and walnut), and gelatin.
. Extreme dietary habits (e.g., intermittent fasting, low carbohydrate diet) that would affect study outcomes as judged by the Principal Investigator.
. Unstable dose of prescription medications (stable is defined as same dose for the past 90 d prior to Visit 1; Day -7).
. Use of prescription drugs (stable or unstable) that have stimulating (e.g., amphetamines \[Adderall® and Dexedrine®\], methylphenidate \[Concerta® and Ritalin®\], diet aids \[such as Didrex®, Bontril®, Preludin®, Fastin®, Adipex P®, Ionomin®, and Meridia®\], containing caffeine or guayusa), cognition boosting, or sedating (e.g., sleeping aids, drugs to treat mental health disorders) effects.
. For females on hormone therapy (including oral contraceptives), the subject must be on a stable dose of hormones (defined as same dose for the past 90 d prior to Visit 1; Day -7).
. Signs or symptoms of an active infection of clinical relevance (e.g., urinary tract or respiratory) within 5 d prior to Visits 2, 3, and 4 (Days 0, 7, and 14). If an infection occurs during the study period, test visits should be rescheduled until all signs and symptoms have resolved (at the discretion of the Principal Investigator) at least 5 d prior to testing, unless the visit will be out of window. If the visit will be out of window, subjects should continue with testing and a protocol deviation will be required.