Guayusa Extract on Exercise Training

NCT05820399 | Completed

• 1 other identifier: 202110443
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (30)

• Desire to Exercise Secondary Measures

  Throughout 6-week training period.

• Exercise Training Performance

  Throughout 6-week training period.

• VO2peak

  baseline, <7 days after completing the intervention

• Submaximal Exercise Fat Oxidation

  baseline, <7 days after completing the intervention

• Submaximal Exercise Blood Pressure

  baseline, <7 days after completing the intervention

Other Outcomes (1)

• Rating of Perceived Exertion

  Throughout 6-week training period.

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

Organic Guayusa Extract 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.

Organic Guayusa Extract + High Intensity Exercise

Placebo DIETARY_SUPPLEMENT

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

Placebo + High Intensity Exercise

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathaniel Jenkins: lead

Study Sites (1)

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, 52242, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized, Double-Blind, Placebo Controlled, Parallel Arm Trial

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 19, 2023
• Study Start: September 5, 2022
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

US (1)