ClinicalTrials.Veeva

Menu

Acute Effects of Organic Guayusa Extract

N

Nathaniel Jenkins

Status

Completed

Conditions

Acute Physiological Effects of Organic Guayusa Extract

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation
Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT05928195
202202283

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

32 participants in 3 patient groups, including a placebo group

Moderate-Dose Guayusa Extract
Experimental group
Description:
Acute, single dose of 600 mg Organic Guayusa Extract
Treatment:
Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation
High-Dose Guayusa Extract
Experimental group
Description:
Acute, single dose of 1200 mg Organic Guayusa Extract
Treatment:
Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation
Placebo
Placebo Comparator group
Description:
Acute, single dose of Placebo (dextrose)
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems