Acute Physiological Effects of Organic Guayusa ExtractNCT05928195
Acute Effects of Organic Guayusa Extract
A study testing Acute Moderate-Dose Guayusa Extract Supplementation and Acute High-Dose Guayusa Extract Supplementation in people with Acute Physiological Effects of Organic Guayusa Extract, run by Nathaniel Jenkins at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Physiological Effects of Organic Guayusa Extract
- What is being tested?
- Acute Moderate-Dose Guayusa Extract Supplementation and Acute High-Dose Guayusa Extract Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2022to 12 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Integrative Laboratory of Applied Physiology and Lifestyle Medicine
Iowa City, Iowa, 52242
About this study
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
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.
Read the 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.
- Being tested
- Acute Moderate-Dose Guayusa Extract Supplementation, Acute High-Dose Guayusa Extract Supplementation, Placebo
- Keywords
- dietary supplementation, cognitive performance, metabolism, heart rate, blood pressure, electrocardiogram, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Moderate-Dose Guayusa Extract SupplementationDietary supplement
Participants will consume two vegan capsules with one capsule containing 600 mg AmaTea® and 1 containing 600 mg dextrose.
Acute High-Dose Guayusa Extract SupplementationDietary supplement
Participants will consume two vegan capsules with each capsule containing 600 mg AmaTea® (1200 mg total).
PlaceboDietary supplement
Participants will consume two vegan capsules with each capsule containing 600 mg dextrose (1200 mg total).
| Study group | Role | What they receive |
|---|---|---|
| Moderate-Dose Guayusa Extract | Experimental | Acute, single dose of 600 mg Organic Guayusa Extract Receives: Dietary Supplement: Acute Moderate-Dose Guayusa Extract Supplementation |
| High-Dose Guayusa Extract | Experimental | Acute, single dose of 1200 mg Organic Guayusa Extract Receives: Dietary Supplement: Acute High-Dose Guayusa Extract Supplementation |
| Placebo | Placebo comparator | Acute, single dose of Placebo (dextrose) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood
Calculated as Total Mood Disturbance (arbitrary units) using the Profile of Mood States Short Form Questionnaire.
Measured: 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.
Measured: 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.
Measured: 60-minutes Post-supplementation
Secondary outcomes (12)
Jitteriness
Participants will describe how jittery they feel after supplemention using a 0-100 mm visual analog scale.
Measured: 90-minutes Post-supplementation
Focus
Participants will describe how focused they feel after supplemention using a 0-100 mm visual analog scale.
Measured: 90-minutes Post-supplementation
Energy
Participants will describe how energetic they feel after supplemention using a 0-100 mm visual analog scale.
Measured: 90-minutes Post-supplementation
Resting Metabolic Rate
Resting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Measured: 50 minutes post-supplementation
Resting Fat Oxidation
Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Measured: 50 minutes post-supplementation
Resting Heart Rate
Heart rate (bpm) will be quantified from a standard 12-lead ECG
Measured: -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.
Measured: -10 minutes before supplementation, 40 minutes post-supplementation
QTc Interval
QTc Interval (ms) will be quantified from a standard 12-lead ECG
Measured: -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
Measured: 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.
Measured: 60-minutes Post-supplementation
Working Memory
How well a subject can perceive and attend to symbols using short-term memory processes.
Measured: 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.
Measured: 60-minutes Post-supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start16 May 2022
- Primary completion13 Jul 2022
- Study completion12 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Physiological Effects of Organic Guayusa ExtractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, placebo-controlled, double-blind, crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nathaniel Jenkins
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nathaniel Jenkins, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928195
- Sponsor's protocol ID
- 202202283
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05928195
- Acronym / sponsor ID
- 202202283
- Keywords
- dietary supplementation, cognitive performance, metabolism, heart rate, blood pressure, electrocardiogram, mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Nathaniel JenkinsUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Jul 2022 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, double-blind, crossover study
| Arm | Type | Receives |
|---|---|---|
| Moderate-Dose Guayusa Extract | Experimental | Dietary Supplement: Acute Moderate-Dose Guayusa Extract SupplementationAcute, single dose of 600 mg Organic Guayusa Extract |
| High-Dose Guayusa Extract | Experimental | Dietary Supplement: Acute High-Dose Guayusa Extract SupplementationAcute, single dose of 1200 mg Organic Guayusa Extract |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboAcute, single dose of Placebo (dextrose) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute Moderate-Dose Guayusa Extract SupplementationParticipants will consume two vegan capsules with one capsule containing 600 mg AmaTea® and 1 containing 600 mg dextrose. | Dietary supplement | Moderate-Dose Guayusa Extract |
| Acute High-Dose Guayusa Extract SupplementationParticipants will consume two vegan capsules with each capsule containing 600 mg AmaTea® (1200 mg total). | Dietary supplement | High-Dose Guayusa Extract |
| PlaceboParticipants will consume two vegan capsules with each capsule containing 600 mg dextrose (1200 mg total). | Dietary supplement | Placebo |
Primary outcome
Mood
Time frame: 90-minutes Post-supplementation
Calculated as Total Mood Disturbance (arbitrary units) using the Profile of Mood States Short Form Questionnaire.
Psychomotor Speed
Time frame: 60-minutes Post-supplementation
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.
Executive Function
Time frame: 60-minutes Post-supplementation
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.
12 secondary outcomes
Jitteriness
Time frame: 90-minutes Post-supplementation
Focus
Time frame: 90-minutes Post-supplementation
Energy
Time frame: 90-minutes Post-supplementation
Resting Metabolic Rate
Time frame: 50 minutes post-supplementation
Resting Fat Oxidation
Time frame: 50 minutes post-supplementation
Resting Heart Rate
Time frame: -10 minutes before supplementation, 40 minutes post-supplementation
Resting Blood Pressure
Time frame: -10 minutes before supplementation, 40 minutes post-supplementation
QTc Interval
Time frame: -10 minutes before supplementation, 40 minutes post-supplementation
Motor-Cognitive Reaction Time
Time frame: 100-minutes Post-supplementation
Sustained Attention
Time frame: 60-minutes Post-supplementation
Working Memory
Time frame: 60-minutes Post-supplementation
Cognitive Flexibility
Time frame: 60-minutes Post-supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Moderate-Dose Guayusa Extract Supplementation and Acute High-Dose Guayusa Extract Supplementation in people with Acute Physiological Effects of Organic Guayusa Extract, run by Nathaniel Jenkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood (time frame: 90-minutes Post-supplementation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.