Effects of Dynamine Ingestion on Various Indices of Sustained Energy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Mood
研究概览
简要总结
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. The objective of this study is to assess the effects of Dynamine (methylliberine) supplementation on overall well-being including energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, and resilience to stress.
详细描述
This study is a randomized, placebo-controlled, double-blind, within-subject crossover trial of 25 men and women. Dynamine (methylliberine) is a caffeine metabolite and purine alkaloid found in the kucha tea leaf. Dynamine has become a popular dietary supplement with consumers due to its neuro-energetic effects. Previous research has shown Dynamine can improve energy, mood and focus without the cardiovascular effects of elevating heart rate or blood pressure.
In this study, participants will attend 5 study visits. During Visit 1, participants will be screened for participation (i.e., medical history, routine blood work, background baseline diet). During Visits 2 and 4, participants will complete baseline testing including subjective questionnaires that assess energy, sustained energy, mental stamina, focus, concentration, motivation to accomplish difficult tasks, drive, vigor, positive outlook, maintaining a healthy mood, feelings of well-being, resilience to stress in addition to completion of a series of an objective neuropsychological test (Stroop test) to assess mental processing, cognitive flexibility, and attention. After three-4- days of supplementation, participants will return for Visit 3 and 5 where they will take a 4th dose of Dynamine or placebo and repeat the testing outlined at previous baseline visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •provide voluntary signed and dated informed consent
- •in good health as determined by physical examination and medical history
- •between the ages of 21 and 55 years
- •body mass index (BMI) of 18.5-27 kg•m-2
- •agrees to abstain from exercise and alcohol for 24 hours prior to each study visit
- •agrees to abstain from coffee and caffeinated beverages for 12 hours prior to each study visit
- •normotensive (seated, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg
- •normal seated, resting heart rate (<90 per minute)
- •willing to duplicate their previous 24-hour and fast for 8 hours prior each study visit
排除标准
- •a history of diabetes or pre-diabetes
- •a history of malignancy in the previous 5 years except for non-melanoma skin cancer
- •prior gastrointestinal bypass surgery
- •known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism
- •any chronic inflammatory condition or disease
- •a known allergy to any of the ingredients in the supplement or the placebo
- •currently participating in another research study with an investigational product or have been in another research study in the previous 30 days
- •a caffeine intake of three or more cups of coffee or equivalent (>400 mg) per day
- •uses corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal)
- •had any other diseases or conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the participant at increased risk of harm if they were to participate
结局指标
主要结局
Mood
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Mood as measured by a 10 cm visual analogue scale, where higher values represent better mood.
Sustained Energy
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Sustained energy as measured by a 10 cm visual analogue scale, where higher values represent increased sustained energy.
Energy
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Energy as measured by a 10 cm visual analogue scale, where higher values represent increased energy.
Cognitive function
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive function as measured by the Stroop Test.
Motivation
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Motivation as measured by a 10 cm visual analogue scale, where higher values represent greater motivation.
Concentration
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Concentration as measured by a 10 cm visual analogue scale, where higher values represent better concentration.
Well-being
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Well-being as measured by a 10 cm visual analogue scale, where higher values represent improved feelings of well-being.
Cognitive flexibility
时间窗: Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.
Cognitive flexibility as measured by the Trail Making Test.
次要结局
- Diastolic blood pressure(Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.)
- Systolic blood pressure(Change from baseline to 60 minutes, 120 minutes, and 180 minutes post-baseline.)