Guayusa Extract on Exercise Training

NCT ID: NCT05820399

Last Updated: 2023-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2022-11-18

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?

Conditions

Desire to Exercise; Exercise Training; Physical Exertion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Organic Guayusa Extract + High Intensity Exercise

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.

Group Type: EXPERIMENTAL

Organic Guayusa Extract

Intervention Type: DIETARY_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.

Placebo + High Intensity Exercise

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Participants will supplement daily with placebo (maltodextrin). Investigators and participants will be blinded to condition.

Interventions

Organic Guayusa Extract

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will supplement daily with placebo (maltodextrin). Investigators and participants will be blinded to condition.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Nathaniel Jenkins

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Jenkins

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202110443

Identifier Type: -

Identifier Source: org_study_id