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临床试验/NCT05928195
NCT05928195已完成不适用

Acute, Dose-Response Effects of Organic Guayusa Extract on Cognitive Performance, Mood, Resting Metabolism, and Blood Pressure, Heart Rate, and Heart Electrical Activity

Nathaniel Jenkins2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
Mood

研究概览

简要总结

Guayusa extract is a caffeinated tea leaf unique blend of antioxidants and caffeine. It is marketed as an ingredient that can help support energy and performance with potential health-related benefits. It has also been indicated as being as safe as any other existing teas (i.e., green tea). However, no studies have previous studied the dose-response effects of guayusa extract for supporting cognitive function, mood, metabolism, nor its effects on resting heart rate, blood pressure, and electrocardiogram characteristics.

详细描述

Guayusa extract is a caffeinated Amazonian 'super-leaf' belonging to the holly species that contains a 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 (e.g., via caffeine content) 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 neurocognitive performance, mood, or otherwise to support health-related goals such as metabolism. 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 these, nor has the dose-effectiveness been tested, in humans.

In this study, the effects of acute dietary supplementation with two different doses of botanical organic guayusa extract on neurocognitive/motor-cognitive performance, mood, focus, and jitteriness, resting metabolism, and resting heart rate, blood pressure, and electrocardiogram characteristics will be examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18-45 years, inclusive
  • Physically active (>=150 min/wk or >=75 min/wk Moderate or Vigorous PA) for >=3 months
  • BMI <= 30 kg/m2
  • Otherwise healthy
  • Habitual caffeine consumption >=200 mg/day OR 1-week washout of current caffeine 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

Mood

时间窗: 90-minutes Post-supplementation

Calculated as Total Mood Disturbance (arbitrary units) using the Profile of Mood States Short Form Questionnaire.

Executive Function

时间窗: 60-minutes Post-supplementation

How well participant recognized rules, categories, and manages or navigates rapid decisions making. Calculated as the differences between Shifting Attention Test Correct Responses and Errors.

Psychomotor Speed

时间窗: 60-minutes Post-supplementation

How well participant perceived, attends, responds to visual-perceptive information, and performs motor speed and fine motor coordination. Calculated as the sum of finger taps in finger tapping test and correct responses in the symbol digit coding test.

次要结局

  • Resting Blood Pressure(-10 minutes before supplementation, 40 minutes post-supplementation)
  • Motor-Cognitive Reaction Time(100-minutes Post-supplementation)
  • Sustained Attention(60-minutes Post-supplementation)
  • Jitteriness(90-minutes Post-supplementation)
  • Cognitive Flexibility(60-minutes Post-supplementation)
  • Focus(90-minutes Post-supplementation)
  • Resting Metabolic Rate(50 minutes post-supplementation)
  • QTc Interval(-10 minutes before supplementation, 40 minutes post-supplementation)
  • Energy(90-minutes Post-supplementation)
  • Resting Fat Oxidation(50 minutes post-supplementation)
  • Resting Heart Rate(-10 minutes before supplementation, 40 minutes post-supplementation)
  • Working Memory(60-minutes Post-supplementation)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nathaniel Jenkins

Assistant Professor

University of Iowa

研究点 (2)

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