Clinical trial NCT05928195: Acute Effects of Organic Guayusa Extract
Official title: Acute, Dose-Response Effects of Organic Guayusa Extract on Cognitive Performance, Mood, Resting Metabolism, and Blood Pressure, Heart Rate, and Heart Electrical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Physiological Effects of Organic Guayusa Extract
Keywords: dietary supplementation
cognitive performance
metabolism
heart rate
blood pressure
electrocardiogram
mood
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, double-blind, crossover study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mood
timeFrame: 90-minutes Post-supplementation
measure: Psychomotor Speed
timeFrame: 60-minutes Post-supplementation
measure: Executive Function
timeFrame: 60-minutes Post-supplementation
Secondary outcomes:
measure: Jitteriness
timeFrame: 90-minutes Post-supplementation
measure: Focus
timeFrame: 90-minutes Post-supplementation
measure: Energy
timeFrame: 90-minutes Post-supplementation
measure: Resting Metabolic Rate
timeFrame: 50 minutes post-supplementation
measure: Resting Fat Oxidation
timeFrame: 50 minutes post-supplementation
measure: Resting Heart Rate
timeFrame: -10 minutes before supplementation, 40 minutes post-supplementation
measure: Resting Blood Pressure
timeFrame: -10 minutes before supplementation, 40 minutes post-supplementation
measure: QTc Interval
timeFrame: -10 minutes before supplementation, 40 minutes post-supplementation
measure: Motor-Cognitive Reaction Time
timeFrame: 100-minutes Post-supplementation
measure: Sustained Attention
timeFrame: 60-minutes Post-supplementation
measure: Working Memory
timeFrame: 60-minutes Post-supplementation
measure: Cognitive Flexibility
timeFrame: 60-minutes Post-supplementation
Other outcomes:
measure: Vigor
timeFrame: 90-minutes Post-supplementation
measure: Tension
timeFrame: 90-minutes Post-supplementation
measure: Fatigue
timeFrame: 90-minutes Post-supplementation
measure: Anger
timeFrame: 90-minutes Post-supplementation
measure: Confusion
timeFrame: 90-minutes Post-supplementation
measure: Stress
timeFrame: 90-minutes Post-supplementation
measure: Composite Memory
timeFrame: 60-minutes Post-supplementation
measure: Reaction Time
timeFrame: 60-minutes Post-supplementation
measure: Complex Attention
timeFrame: 60-minutes Post-supplementation
measure: Reasoning
timeFrame: 60-minutes Post-supplementation
Locations:
city: Iowa City
country: United States
facility: Integrative Laboratory of Applied Physiology and Lifestyle Medicine
state: Iowa
Study officials:
References: