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 range18 Years – 55 Years
SexALL
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).
✓. 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.
What they're measuring
1
Mental alertness
Timeframe: Change from pre-dose baseline to 60 minutes post-guayusa consumption compared to placebo
✕. 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.