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Acute Effects of Organic Guayusa Extract

Acute, Dose-Response Effects of Organic Guayusa Extract on Cognitive Performance, Mood, Resting Metabolism, and Blood Pressure, Heart Rate, and Heart Electrical Activity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05928195
Enrollment
32
Registered
2023-07-03
Start date
2022-05-16
Completion date
2023-04-12
Last updated
2023-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Physiological Effects of Organic Guayusa Extract

Keywords

dietary supplementation, cognitive performance, metabolism, heart rate, blood pressure, electrocardiogram, mood

Brief summary

Guayusa extract is a caffeinated tea leaf unique blend of antioxidants and caffeine. It is marketed as an ingredient that can help support energy and performance with potential health-related benefits. It has also been indicated as being as safe as any other existing teas (i.e., green tea). However, no studies have previous studied the dose-response effects of guayusa extract for supporting cognitive function, mood, metabolism, nor its effects on resting heart rate, blood pressure, and electrocardiogram characteristics.

Detailed description

Guayusa extract is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a unique blend of polyphenol antioxidants and caffeine (\ 20% caffeine, 30% chlorogenic acids, 5% catechins). It is also remarkably low in tannins which are responsible for the bitter taste found in most teas - giving it a sweet flavor profile. As such, it is marketed as an ingredient that can help support energy and performance (e.g., via caffeine content) with potential health-related benefits due to its antioxidant properties. Indeed, ingredients such as these are often consumed by individuals prior to exercise in order to help improve neurocognitive performance, mood, or otherwise to support health-related goals such as metabolism. Whereas several studies have suggested that caffeine and chlorogenic acid consumption may improve performance, mood, and concentration, and some evidence in animals have linked catechin consumption to improved health outcomes, no studies have previous studied whether guayusa extract supplementation helps to support these, nor has the dose-effectiveness been tested, in humans. In this study, the effects of acute dietary supplementation with two different doses of botanical organic guayusa extract on neurocognitive/motor-cognitive performance, mood, focus, and jitteriness, resting metabolism, and resting heart rate, blood pressure, and electrocardiogram characteristics will be examined.

Interventions

DIETARY_SUPPLEMENTAcute Moderate-Dose Guayusa Extract Supplementation

Participants will consume two vegan capsules with one capsule containing 600 mg AmaTea® and 1 containing 600 mg dextrose.

DIETARY_SUPPLEMENTAcute High-Dose Guayusa Extract Supplementation

Participants will consume two vegan capsules with each capsule containing 600 mg AmaTea® (1200 mg total).

DIETARY_SUPPLEMENTPlacebo

Participants will consume two vegan capsules with each capsule containing 600 mg dextrose (1200 mg total).

Sponsors

Nathaniel Jenkins
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomized, placebo-controlled, double-blind, crossover study

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* 18-45 years, inclusive * Physically active (\>=150 min/wk or \>=75 min/wk Moderate or Vigorous PA) for \>=3 months * BMI \<= 30 kg/m2 * Otherwise healthy * Habitual caffeine consumption \>=200 mg/day OR 1-week washout of current caffeine usage prior to participation

Exclusion criteria

* Current injury or illness that precludes exercise participation * Current nicotine or cannabis use * Use of prescription ADD/ADHD, anti-depressant, or other central acting medication, or previously diagnosed ADD/ADHD, clinically depressed, or generalized anxiety disorder * Current taking prescription stimulants (i.e., Adderall, Ritalin, Vyvanse, etc.) * Participants with a history of metabolic, hepatorenal, musculoskeletal, autoimmune, or neurologic disease; or currently taking thyroid, hormonal, hyperlipidemic, hypoglycemic, anti-hypertensive, anti-inflammatory, or anti-coagulant medications. * Treated for Metabolic Syndrome or having been clinically diagnosed with, or taking medication for a cardiometabolic-disorder (e.g., Pre-diabetes, Type II diabetes, high blood pressure, obesity, hypercholesterolemia, etc.) * Currently pregnant or lactating * Diagnosed allergy to any ingredient present within the study treatments * Current competitive NCAA athlete * Inability or unwillingness to comply with the controls and conditions of the study

Design outcomes

Primary

MeasureTime frameDescription
Mood90-minutes Post-supplementationCalculated as Total Mood Disturbance (arbitrary units) using the Profile of Mood States Short Form Questionnaire.
Executive Function60-minutes Post-supplementationHow well participant recognized rules, categories, and manages or navigates rapid decisions making. Calculated as the differences between Shifting Attention Test Correct Responses and Errors.
Psychomotor Speed60-minutes Post-supplementationHow well participant perceived, attends, responds to visual-perceptive information, and performs motor speed and fine motor coordination. Calculated as the sum of finger taps in finger tapping test and correct responses in the symbol digit coding test.

Secondary

MeasureTime frameDescription
Energy90-minutes Post-supplementationParticipants will describe how energetic they feel after supplemention using a 0-100 mm visual analog scale.
Focus90-minutes Post-supplementationParticipants will describe how focused they feel after supplemention using a 0-100 mm visual analog scale.
Resting Metabolic Rate50 minutes post-supplementationResting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Resting Fat Oxidation50 minutes post-supplementationResting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Resting Heart Rate-10 minutes before supplementation, 40 minutes post-supplementationHeart rate (bpm) will be quantified from a standard 12-lead ECG
Resting Blood Pressure-10 minutes before supplementation, 40 minutes post-supplementationSystolic, diastolic, and pulse pressures (mmHg) will be quantified from brachial artery via automated sphygmomanometer.
QTc Interval-10 minutes before supplementation, 40 minutes post-supplementationQTc Interval (ms) will be quantified from a standard 12-lead ECG
Motor-Cognitive Reaction Time100-minutes Post-supplementationMotor-cognitive reaction times (ms) will be quantified from motor cognitive (reactionary hop) tests
Sustained Attention60-minutes Post-supplementationHow well a subject can direct and focus cognitive activity on specific stimuli. Derived from performance on the 4-part continuous performance task test.
Working Memory60-minutes Post-supplementationHow well a subject can perceive and attend to symbols using short-term memory processes.
Cognitive Flexibility60-minutes Post-supplementationHow well subject is able to adapt to rapidly changing and increasingly complex set of directions and/or to manipulate the information. Assessed from the Shifting Attention Task and Stoop Test as the Shifting Attention Task Correct Responses - Shifting Attention Task Incorrect Responses and Stroop Commission Errors.
Jitteriness90-minutes Post-supplementationParticipants will describe how jittery they feel after supplemention using a 0-100 mm visual analog scale.

Other

MeasureTime frameDescription
Confusion90-minutes Post-supplementationConfusion will be quantified using the Profile of Mood State Short Form Questionnaire.
Stress90-minutes Post-supplementationStress will be quantified using the Profile of Mood State Short Form Questionnaire.
Composite Memory60-minutes Post-supplementationHow well subject can recognize, remember, and retrieve words and geometric figures. Assessed as a composite performance indicator during the Verbal Memory and Visual Memory Tests.
Reaction Time60-minutes Post-supplementationHow quickly the subject can react, in milliseconds, to a simple and increasingly complex direction set.
Complex Attention60-minutes Post-supplementationAbility to track and respond to a variety of stimuli over lengthy periods of time and/or perform mental tasks requiring vigilance quickly and accurately.
Reasoning60-minutes Post-supplementationHow well is subject able to recognize, reason and respond to non-verbal visual-abstract stimuli. Assessed from the non-verbal reasoning test as the difference between the number of correct responses and commission errors.
Fatigue90-minutes Post-supplementationFatigue will be quantified using the Profile of Mood State Short Form Questionnaire.
Tension90-minutes Post-supplementationTension will be quantified using the Profile of Mood State Short Form Questionnaire.
Vigor90-minutes Post-supplementationVigor will be quantified using the Profile of Mood State Short Form Questionnaire.
Anger90-minutes Post-supplementationAnger will be quantified using the Profile of Mood State Short Form Questionnaire.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026