Desire to ExerciseNCT05820399
Guayusa Extract on Exercise Training
A study testing Organic Guayusa Extract in people with Desire to Exercise and Exercise Training, run by Nathaniel Jenkins at 1 site in United States.
Trial summary
Guayusa extract is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a very unique blend of polyphenol antioxidants and caffeine (~20% caffeine, 30% chlorogenic acids, 5% catechins). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Desire to Exercise, Exercise Training, Physical Exertion
- What is being tested?
- Organic Guayusa Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2022to 18 Nov 2022
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females
- 18-45 years, inclusive
- Physically active >=150 min/wk Moderate Intensity or >=75 min/wk Vigorous Intensity PA) for >=3 months
- BMI < 35 kg/m2
- Otherwise healthy and ready to participate in an exercise program as indicated by responses on the 2021 Physical Activity Readiness Questionnaire Plus (PAR-Q+)
- Habitual caffeine consumption <=200 mg/day OR 2-week washout of current caffeine usage prior to participation
- No current dietary supplementation OR 2-week washout of current supplement 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.)
Show all 10Show fewer
- 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: Ability of Organic Guayusa Extract to Augment Desire to Train, Training Load, and Cardiometabolic Function in Physically Active Women Performing A High Intensity Exercise Training Program
Guayusa extract is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a very 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 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 exercise performance, or otherwise to support health-related goals. 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 exercise performance in humans. In this study, we will test the whether dietary supplementation with the botanical organic guayusa extract helps support (1) the desire to exercise and exercise performance throughout a 6-week high intensity exercise training program, and thus (2) helps support the physiological adaptations (including body composition, fasting metabolic biomarkers, blood pressure and heart rate, submaximal and maximal exercise performance and fuel metabolism, and changes in the gut microbiome/mycobiome) to a 6-week high intensity exercise training program.
Question 1: Does organic guayusa extract supplementation support the desire to train and training load in physically-active women performing a high-intensity exercise training program?
Question 2: Does organic guayusa extract supplementation support physiological adaptation to exercise (including body composition, fasting metabolic biomarkers, blood pressure and heart rate, submaximal and maximal exercise performance and fuel metabolism, and changes in the gut microbiome/mycobiome) in physically-active women performing a high-intensity exercise training program?
- Conditions
- Desire to Exercise, Exercise Training, Physical Exertion
- Being tested
- Organic Guayusa Extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic Guayusa ExtractDietary supplement
Supplementation: Participants will supplement daily with organic guayusa extract, which is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a very unique blend of polyphenol antioxidants and caffeine (~20% caffeine, 30% chlorogenic acids, 5% catechins) during 6 weeks of high intensity exercise training. Investigators and participants will be blinded to condition.
PlaceboDietary supplement
Participants will supplement daily with placebo (maltodextrin). Investigators and participants will be blinded to condition.
| Study group | Role | What they receive |
|---|---|---|
| Organic Guayusa Extract + High Intensity Exercise | Experimental | Participants will consume an organic guayusa extract supplement that contains caffeine and antioxidants each day for 6 weeks while completing the exercise training program on 3 days/week. On days that participants exercise, they will consume the supplement 30-60 minutes before exercise training. On days they do not exercise, they will consume the capsules upon waking. Receives: Dietary Supplement: Organic Guayusa Extract |
| Placebo + High Intensity Exercise | Placebo comparator | Participants will consume a placebo consisting of maltodextrin each day for 6 weeks while completing the exercise training program. The placebo will be provided in capsule identical in appearance to the active supplement. On days that participants exercise, they will consume the placebo 30-60 minutes before exercise training. On days they do not exercise, they will consume the capsules upon waking. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desire to Exercise
Desire to Exercise will be assessed Primarily via the Assessment of Exercise Readiness using a 41-item Exercise Readiness Questionnaire.
Measured: Throughout 6-week training period.
Exercise Adherence
Exercise training session adherence will be assessed across all exercise training sessions as a primary quantitative indicator of desire to exercise. Adherence will be assessed as the actual number of completed exercise sessions among participants in each group relative (i.e., percent, %) to the number of total planned exercise sessions. Group differences in session adherence will be compared by chi squared tests.
Measured: Throughout 6-week training period.
Exercise Training Load
Resistance Exercise Training Volume (normalized to bodyweight) will be quantified in each resistance training workout (2x/week) and used as a quantitative indicator of exercise performance/effort.
Measured: Throughout 6-week training period.
Secondary outcomes (30)
Desire to Exercise Secondary Measures
Secondary assessments of Desire to Exercise will include visual analog scales (range 0 - 50, with 0 indicating lower desire and 50 indicating higher desire) used to assess readiness immediately before exercise sessions to "exercise right now", to "invest physical energy right now" and to "invest mental energy right now".
Measured: Throughout 6-week training period.
Exercise Training Performance
Secondary assessments of exercise training performance will include performance during a) a weekly airbike interval exercise session (Avg W), b) a weekly 500 m row (time to completion, Avg W), and c) the time (min) taken to complete the weekly metabolic conditioning workout.
Measured: Throughout 6-week training period.
VO2peak
VO2peak will be assessed during a ramp test on a electronically-braked cycle ergometer performed to volitional exhaustion with pulmonary gas exchange analysis.
Measured: baseline, <7 days after completing the intervention
Submaximal Exercise Fat Oxidation
Submaximal Exercise Fat Oxidation (%) will be assessed during exercise at a fixed power (i.e., 75W) on an electronically-braked cycle ergometer with pulmonary gas exchange analysis.
Measured: baseline, <7 days after completing the intervention
Submaximal Exercise Blood Pressure
Submaximal Systolic and Diastolic Exercise Blood Pressure (mmHg) will be assessed during exercise at a fixed power (75W) on an electronically-braked cycle ergometer.
Measured: baseline, <7 days after completing the intervention
Fasting metabolic biomarkers
Total cholesterol, HDL-cholesterol, LDL-cholesterol, non-HDL cholesterol, triglycerides, glucose, insulin, c-peptide, GLP-1, GIP
Measured: baseline, <7 days after completing the intervention
Fasting total cholesterol
Total cholesterol will be assessed from a fasting blood sample.
Measured: baseline, <7 days after completing the intervention
Fasting HDL-cholesterol
HDL-cholesterol will be assessed from a fasting blood sample.
Measured: baseline, <7 days after completing the intervention
Fasting non-HDL cholesterol
Non-HDL cholesterol will be assessed from a fasting blood sample.
Measured: baseline, <7 days after completing the intervention
Fasting triglycerides
Triglycerides will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Glucose
Glucose will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting insulin
insulin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting c-peptide
Fasting c-peptide will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting GLP-1
Fasting GLP-1 will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting GIP
Fasting GIP will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting IL-6
IL-6 will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting IL-10
IL-10 will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting TNFa
TNFa will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting triiodothyronine (T3)
Triiodothyronine (T3) will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting thyroxine (T4)
Thyroxine (T4) will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Progesterone
Progesterone will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Testosterone
Testosterone will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Estrogen
Estrogen will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Cortisol
Cortisol will be assessed from a fasting blood sample
Measured: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Adiponectin
Adiponectin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Leptin
Leptin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Adipsin
Adipsin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Lipocalin
Lipocalin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Plasminogen activator inhibitor-1 (PAI-1)
Plasminogen activator inhibitor-1 (PAI-1) will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Fasting Resistin
Resistin will be assessed from a fasting blood sample
Measured: baseline, <7 days after completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start5 Sep 2022
- Primary completion18 Nov 2022
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desire to ExerciseStudies 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
- Parallel groups
- Model description
- Randomized, Double-Blind, Placebo Controlled, Parallel Arm Trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 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
- NCT05820399
- Sponsor's protocol ID
- 202110443
- Status last verified
- Apr 2023
- First submitted
- 24 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Organic Guayusa Extract to Augment Desire to Train, Training Load, and Cardiometabolic Function in Physically Active Women Performing A High Intensity Exercise Training Program
- ClinicalTrials.gov ID
- NCT05820399
- Acronym / sponsor ID
- 202110443
- Conditions
- Desire to Exercise, Exercise Training, Physical Exertion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Nathaniel JenkinsUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 19 Apr 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 Amazonian 'super-leaf' belonging to the holly species that contains a very 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 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 exercise performance, or otherwise to support health-related goals. 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 exercise performance in humans. In this study, we will test the whether dietary supplementation with the botanical organic guayusa extract helps support (1) the desire to exercise and exercise performance throughout a 6-week high intensity exercise training program, and thus (2) helps support the physiological adaptations (including body composition, fasting metabolic biomarkers, blood pressure and heart rate, submaximal and maximal exercise performance and fuel metabolism, and changes in the gut microbiome/mycobiome) to a 6-week high intensity exercise training program.
Question 1: Does organic guayusa extract supplementation support the desire to train and training load in physically-active women performing a high-intensity exercise training program?
Question 2: Does organic guayusa extract supplementation support physiological adaptation to exercise (including body composition, fasting metabolic biomarkers, blood pressure and heart rate, submaximal and maximal exercise performance and fuel metabolism, and changes in the gut microbiome/mycobiome) in physically-active women performing a high-intensity exercise training program?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-Blind, Placebo Controlled, Parallel Arm Trial
| Arm | Type | Receives |
|---|---|---|
| Organic Guayusa Extract + High Intensity Exercise | Experimental | Dietary Supplement: Organic Guayusa ExtractParticipants will consume an organic guayusa extract supplement that contains caffeine and antioxidants each day for 6 weeks while completing the exercise training program on 3 days/week. On days that participants exercise, they will consume the supplement 30-60 minutes before exercise training. On days they do not exercise, they will consume the capsules upon waking. |
| Placebo + High Intensity Exercise | Placebo comparator | Dietary Supplement: PlaceboParticipants will consume a placebo consisting of maltodextrin each day for 6 weeks while completing the exercise training program. The placebo will be provided in capsule identical in appearance to the active supplement. On days that participants exercise, they will consume the placebo 30-60 minutes before exercise training. On days they do not exercise, they will consume the capsules upon waking. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females
- 18-45 years, inclusive
- Physically active >=150 min/wk Moderate Intensity or >=75 min/wk Vigorous Intensity PA) for >=3 months
- BMI < 35 kg/m2
- Otherwise healthy and ready to participate in an exercise program as indicated by responses on the 2021 Physical Activity Readiness Questionnaire Plus (PAR-Q+)
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 |
|---|---|---|
| Organic Guayusa ExtractSupplementation: Participants will supplement daily with organic guayusa extract, which is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a very unique blend of polyphenol antioxidants and caffeine (~20% caffeine, 30% chlorogenic acids, 5% catechins) during 6 weeks of high intensity exercise training. Investigators and participants will be blinded to condition. | Dietary supplement | Organic Guayusa Extract + High Intensity Exercise |
| PlaceboParticipants will supplement daily with placebo (maltodextrin). Investigators and participants will be blinded to condition. | Dietary supplement | Placebo + High Intensity Exercise |
Primary outcome
Desire to Exercise
Time frame: Throughout 6-week training period.
Desire to Exercise will be assessed Primarily via the Assessment of Exercise Readiness using a 41-item Exercise Readiness Questionnaire.
Exercise Adherence
Time frame: Throughout 6-week training period.
Exercise training session adherence will be assessed across all exercise training sessions as a primary quantitative indicator of desire to exercise. Adherence will be assessed as the actual number of completed exercise sessions among participants in each group relative (i.e., percent, %) to the number of total planned exercise sessions. Group differences in session adherence will be compared by chi squared tests.
Exercise Training Load
Time frame: Throughout 6-week training period.
Resistance Exercise Training Volume (normalized to bodyweight) will be quantified in each resistance training workout (2x/week) and used as a quantitative indicator of exercise performance/effort.
30 secondary outcomes
Desire to Exercise Secondary Measures
Time frame: Throughout 6-week training period.
Exercise Training Performance
Time frame: Throughout 6-week training period.
VO2peak
Time frame: baseline, <7 days after completing the intervention
Submaximal Exercise Fat Oxidation
Time frame: baseline, <7 days after completing the intervention
Submaximal Exercise Blood Pressure
Time frame: baseline, <7 days after completing the intervention
Fasting metabolic biomarkers
Time frame: baseline, <7 days after completing the intervention
Fasting total cholesterol
Time frame: baseline, <7 days after completing the intervention
Fasting HDL-cholesterol
Time frame: baseline, <7 days after completing the intervention
Fasting non-HDL cholesterol
Time frame: baseline, <7 days after completing the intervention
Fasting triglycerides
Time frame: baseline, <7 days after completing the intervention
Fasting Glucose
Time frame: baseline, <7 days after completing the intervention
Fasting insulin
Time frame: baseline, <7 days after completing the intervention
Fasting c-peptide
Time frame: baseline, <7 days after completing the intervention
Fasting GLP-1
Time frame: baseline, <7 days after completing the intervention
Fasting GIP
Time frame: baseline, <7 days after completing the intervention
Fasting IL-6
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting IL-10
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting TNFa
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting triiodothyronine (T3)
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting thyroxine (T4)
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Progesterone
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Testosterone
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Estrogen
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Cortisol
Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention
Fasting Adiponectin
Time frame: baseline, <7 days after completing the intervention
Fasting Leptin
Time frame: baseline, <7 days after completing the intervention
Fasting Adipsin
Time frame: baseline, <7 days after completing the intervention
Fasting Lipocalin
Time frame: baseline, <7 days after completing the intervention
Fasting Plasminogen activator inhibitor-1 (PAI-1)
Time frame: baseline, <7 days after completing the intervention
Fasting Resistin
Time frame: baseline, <7 days after completing the intervention
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 19 Apr 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 Organic Guayusa Extract in people with Desire to Exercise and Exercise Training, 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 7 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 19 Apr 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?
Desire to Exercise (time frame: Throughout 6-week training period.). 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 19 Apr 2023.