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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Exercise Training Load
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Exercise Training Load
时间窗: Throughout 6-week training period.
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.
Desire to Exercise
时间窗: Throughout 6-week training period.
Desire to Exercise will be assessed Primarily via the Assessment of Exercise Readiness using a 41-item Exercise Readiness Questionnaire.
Exercise Adherence
时间窗: Throughout 6-week training period.
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.
次要结局
- Fasting Progesterone(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- VO2peak(baseline, <7 days after completing the intervention)
- Submaximal Exercise Fat Oxidation(baseline, <7 days after completing the intervention)
- Fasting total cholesterol(baseline, <7 days after completing the intervention)
- Fasting triiodothyronine (T3)(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting Estrogen(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting Adipsin(baseline, <7 days after completing the intervention)
- Fasting Plasminogen activator inhibitor-1 (PAI-1)(baseline, <7 days after completing the intervention)
- Fasting HDL-cholesterol(baseline, <7 days after completing the intervention)
- Fasting Glucose(baseline, <7 days after completing the intervention)
- Fasting insulin(baseline, <7 days after completing the intervention)
- Fasting Resistin(baseline, <7 days after completing the intervention)
- Fasting Cortisol(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting Testosterone(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Desire to Exercise Secondary Measures(Throughout 6-week training period.)
- Fasting non-HDL cholesterol(baseline, <7 days after completing the intervention)
- Fasting GLP-1(baseline, <7 days after completing the intervention)
- Fasting IL-10(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting thyroxine (T4)(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting Adiponectin(baseline, <7 days after completing the intervention)
- Exercise Training Performance(Throughout 6-week training period.)
- Submaximal Exercise Blood Pressure(baseline, <7 days after completing the intervention)
- Fasting metabolic biomarkers(baseline, <7 days after completing the intervention)
- Fasting triglycerides(baseline, <7 days after completing the intervention)
- Fasting c-peptide(baseline, <7 days after completing the intervention)
- Fasting GIP(baseline, <7 days after completing the intervention)
- Fasting IL-6(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting TNFa(baseline, at 1 week during the intervention, <7 days after completing the intervention)
- Fasting Leptin(baseline, <7 days after completing the intervention)
- Fasting Lipocalin(baseline, <7 days after completing the intervention)
研究者
Nathaniel Jenkins
Assistant Professor
University of Iowa