Acute Effects of Organic Guayusa Extract

NCT05928195 | Completed DMC

• 1 other identifier: 202202283
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Physiological Effects of Organic Guayusa Extract

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• Jitteriness

  90-minutes Post-supplementation

• Focus

  90-minutes Post-supplementation

• Energy

  90-minutes Post-supplementation

• Resting Metabolic Rate

  50 minutes post-supplementation

• Resting Fat Oxidation

  50 minutes post-supplementation

Other Outcomes (10)

• Vigor

  90-minutes Post-supplementation

• Tension

  90-minutes Post-supplementation

• Fatigue

  90-minutes Post-supplementation

Study Arms (3)

Moderate-Dose Guayusa Extract

EXPERIMENTAL

Acute, single dose of 600 mg Organic Guayusa Extract

Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation

High-Dose Guayusa Extract

EXPERIMENTAL

Acute, single dose of 1200 mg Organic Guayusa Extract

Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation

Placebo

PLACEBO COMPARATOR

Acute, single dose of Placebo (dextrose)

Dietary Supplement: Placebo

Interventions

Acute Moderate-Dose Guayusa Extract Supplementation DIETARY_SUPPLEMENT

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

Moderate-Dose Guayusa Extract

Acute High-Dose Guayusa Extract Supplementation DIETARY_SUPPLEMENT

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

High-Dose Guayusa Extract

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathaniel Jenkins: lead

Study Sites (1)

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, 52242, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, placebo-controlled, double-blind, crossover study

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: July 3, 2023
• Study Start: May 16, 2022
• Primary Completion: July 13, 2022
• Study Completion: April 12, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Locations

US (1)