Acute Effects of Organic Guayusa Extract

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Physiological Effects of Organic Guayusa Extract

Intervention / Treatment
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* Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation
* Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, placebo-controlled, double-blind, crossover study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate-Dose Guayusa Extract<br>Acute, single dose of 600 mg Organic Guayusa Extract | Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation<br>* Participants will consume two vegan capsules with one capsule containing 600 mg AmaTea® and 1 containing 600 mg dextrose.<br>|
| Experimental: High-Dose Guayusa Extract<br>Acute, single dose of 1200 mg Organic Guayusa Extract | Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation<br>* Participants will consume two vegan capsules with each capsule containing 600 mg AmaTea® (1200 mg total).<br>|
| Placebo Comparator: Placebo<br>Acute, single dose of Placebo (dextrose) | Dietary Supplement: Placebo<br>* Participants will consume two vegan capsules with each capsule containing 600 mg dextrose (1200 mg total).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood | Calculated as Total Mood Disturbance (arbitrary units) using the Profile of Mood States Short Form Questionnaire. | 90-minutes Post-supplementation | 
| Psychomotor Speed | How 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. | 60-minutes Post-supplementation | 
| Executive Function | How well participant recognized rules, categories, and manages or navigates rapid decisions making. Calculated as the differences between Shifting Attention Test Correct Responses and Errors. | 60-minutes Post-supplementation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jitteriness | Participants will describe how jittery they feel after supplemention using a 0-100 mm visual analog scale. | 90-minutes Post-supplementation | 
| Focus | Participants will describe how focused they feel after supplemention using a 0-100 mm visual analog scale. | 90-minutes Post-supplementation | 
| Energy | Participants will describe how energetic they feel after supplemention using a 0-100 mm visual analog scale. | 90-minutes Post-supplementation | 
| Resting Metabolic Rate | Resting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange. | 50 minutes post-supplementation | 
| Resting Fat Oxidation | Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange. | 50 minutes post-supplementation | 
| Resting Heart Rate | Heart rate (bpm) will be quantified from a standard 12-lead ECG | -10 minutes before supplementation, 40 minutes post-supplementation | 
| Resting Blood Pressure | Systolic, diastolic, and pulse pressures (mmHg) will be quantified from brachial artery via automated sphygmomanometer. | -10 minutes before supplementation, 40 minutes post-supplementation | 
| QTc Interval | QTc Interval (ms) will be quantified from a standard 12-lead ECG | -10 minutes before supplementation, 40 minutes post-supplementation | 
| Motor-Cognitive Reaction Time | Motor-cognitive reaction times (ms) will be quantified from motor cognitive (reactionary hop) tests | 100-minutes Post-supplementation | 
| Sustained Attention | How well a subject can direct and focus cognitive activity on specific stimuli. Derived from performance on the 4-part continuous performance task test. | 60-minutes Post-supplementation | 
| Working Memory | How well a subject can perceive and attend to symbols using short-term memory processes. | 60-minutes Post-supplementation | 
| Cognitive Flexibility | How 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. | 60-minutes Post-supplementation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary supplementation, cognitive performance, metabolism, heart rate, blood pressure, electrocardiogram, mood