Guayusa Extract on Exercise Training

N/ACompletedNCT05820399

Nathaniel Jenkins57 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Desire to Exercise

Desire to Exercise will be assessed Primarily via the Assessment of Exercise Readiness using a 41-item Exercise Readiness Questionnaire.

Time frame: 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.

Time frame: 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.

Time frame: Throughout 6-week training period.

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: baseline, <7 days after completing the intervention

Fasting total cholesterol

Total cholesterol will be assessed from a fasting blood sample.

Time frame: baseline, <7 days after completing the intervention

Fasting HDL-cholesterol

HDL-cholesterol will be assessed from a fasting blood sample.

Time frame: baseline, <7 days after completing the intervention

Fasting non-HDL cholesterol

Non-HDL cholesterol will be assessed from a fasting blood sample.

Time frame: baseline, <7 days after completing the intervention

Fasting triglycerides

Triglycerides will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting Glucose

Glucose will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting insulin

insulin will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting c-peptide

Fasting c-peptide will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting GLP-1

Fasting GLP-1 will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting GIP

Fasting GIP will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting IL-6

IL-6 will be assessed from a fasting blood sample

Time frame: 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

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting TNFa

TNFa will be assessed from a fasting blood sample

Time frame: 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

Time frame: 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

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting Progesterone

Progesterone will be assessed from a fasting blood sample

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting Testosterone

Testosterone will be assessed from a fasting blood sample

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting Estrogen

Estrogen will be assessed from a fasting blood sample

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting Cortisol

Cortisol will be assessed from a fasting blood sample

Time frame: baseline, at 1 week during the intervention, <7 days after completing the intervention

Fasting Adiponectin

Adiponectin will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting Leptin

Leptin will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting Adipsin

Adipsin will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Fasting Lipocalin

Lipocalin will be assessed from a fasting blood sample

Time frame: 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

Time frame: baseline, <7 days after completing the intervention

Fasting Resistin

Resistin will be assessed from a fasting blood sample

Time frame: baseline, <7 days after completing the intervention

Guayusa Extract on Exercise Training

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes