Acute Effects of Organic Guayusa Extract

NCT ID: NCT05928195

Last Updated: 2023-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-16
• Study Completion Date: 2023-04-12

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.

Conditions

Acute Physiological Effects of Organic Guayusa Extract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Moderate-Dose Guayusa Extract

Acute, single dose of 600 mg Organic Guayusa Extract

Group Type: EXPERIMENTAL

Acute Moderate-Dose Guayusa Extract Supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

High-Dose Guayusa Extract

Acute, single dose of 1200 mg Organic Guayusa Extract

Group Type: EXPERIMENTAL

Acute High-Dose Guayusa Extract Supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Acute, single dose of Placebo (dextrose)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Acute Moderate-Dose Guayusa Extract Supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Acute High-Dose Guayusa Extract Supplementation

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nathaniel Jenkins

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Jenkins

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202202283

Identifier Type: -

Identifier Source: org_study_id