Clinical trial NCT05820399: Guayusa Extract on Exercise Training
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Desire to Exercise
Exercise Training
Physical Exertion
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo Controlled, Parallel Arm Trial
Primary purpose: OTHER

Brief 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). 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?


Eligibility criteria: 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

Primary outcomes:
measure: Desire to Exercise
timeFrame: Throughout 6-week training period.
measure: Exercise Adherence
timeFrame: Throughout 6-week training period.
measure: Exercise Training Load
timeFrame: Throughout 6-week training period.
Secondary outcomes:
measure: Desire to Exercise Secondary Measures
timeFrame: Throughout 6-week training period.
measure: Exercise Training Performance
timeFrame: Throughout 6-week training period.
measure: VO2peak
timeFrame: baseline, <7 days after completing the intervention
measure: Submaximal Exercise Fat Oxidation
timeFrame: baseline, <7 days after completing the intervention
measure: Submaximal Exercise Blood Pressure
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting metabolic biomarkers
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting total cholesterol
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting HDL-cholesterol
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting non-HDL cholesterol
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting triglycerides
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Glucose
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting insulin
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting c-peptide
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting GLP-1
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting GIP
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting IL-6
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting IL-10
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting TNFa
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting triiodothyronine (T3)
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting thyroxine (T4)
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting Progesterone
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting Testosterone
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting Estrogen
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting Cortisol
timeFrame: baseline, at 1 week during the intervention, <7 days after completing the intervention
measure: Fasting Adiponectin
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Leptin
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Adipsin
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Lipocalin
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Plasminogen activator inhibitor-1 (PAI-1)
timeFrame: baseline, <7 days after completing the intervention
measure: Fasting Resistin
timeFrame: baseline, <7 days after completing the intervention
Other outcomes:
measure: Rating of Perceived Exertion
timeFrame: Throughout 6-week training period.
Locations:
city: Iowa City
country: United States
facility: Integrative Laboratory of Applied Physiology and Lifestyle Medicine
state: Iowa
Study officials:
References: