Guayusa Extract on Exercise Training

Study Overview
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Brief Summary
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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?

Official Title
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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

Conditions
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Desire to Exercise, Exercise Training, Physical Exertion

Intervention / Treatment
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* Dietary Supplement: Organic Guayusa Extract
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Double-Blind, Placebo Controlled, Parallel Arm Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Organic Guayusa Extract + High Intensity Exercise<br>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. | Dietary Supplement: Organic Guayusa Extract<br>* 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.<br>|
| Placebo Comparator: Placebo + High Intensity Exercise<br>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. | Dietary Supplement: Placebo<br>* Participants will supplement daily with placebo (maltodextrin). Investigators and participants will be blinded to condition.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desire to Exercise | Desire to Exercise will be assessed Primarily via the Assessment of Exercise Readiness using a 41-item Exercise Readiness Questionnaire. | 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. | 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. | Throughout 6-week training period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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 | baseline, <7 days after completing the intervention | 
| Fasting total cholesterol | Total cholesterol will be assessed from a fasting blood sample. | baseline, <7 days after completing the intervention | 
| Fasting HDL-cholesterol | HDL-cholesterol will be assessed from a fasting blood sample. | baseline, <7 days after completing the intervention | 
| Fasting non-HDL cholesterol | Non-HDL cholesterol will be assessed from a fasting blood sample. | baseline, <7 days after completing the intervention | 
| Fasting triglycerides | Triglycerides will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting Glucose | Glucose will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting insulin | insulin will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting c-peptide | Fasting c-peptide will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting GLP-1 | Fasting GLP-1 will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting GIP | Fasting GIP will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting IL-6 | IL-6 will be assessed from a fasting blood sample | 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 | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting TNFa | TNFa will be assessed from a fasting blood sample | 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 | 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 | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting Progesterone | Progesterone will be assessed from a fasting blood sample | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting Testosterone | Testosterone will be assessed from a fasting blood sample | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting Estrogen | Estrogen will be assessed from a fasting blood sample | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting Cortisol | Cortisol will be assessed from a fasting blood sample | baseline, at 1 week during the intervention, <7 days after completing the intervention | 
| Fasting Adiponectin | Adiponectin will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting Leptin | Leptin will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting Adipsin | Adipsin will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention | 
| Fasting Lipocalin | Lipocalin will be assessed from a fasting blood sample | 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 | baseline, <7 days after completing the intervention | 
| Fasting Resistin | Resistin will be assessed from a fasting blood sample | baseline, <7 days after completing the intervention |