A Randomized, Decentralized, Crossover, Open-Label Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Subjective caffeine visual analog scales
研究概览
简要总结
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.
详细描述
This will evaluate post-beverage subjective caffeine responses using visual analog scale questionnaires, mood, quality of life, and physiological responses to caffeine beverages compared to participants' habitual caffeine beverage intake in generally healthy adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, ≥18 to ≤55 years of age
- •BMI ≥18.5 and <29.9 kg/m2
- •Generally good health
- •Participant currently and consistently has a caffeine routine
- •Participant is willing to substitute their current caffeine routine for the test beverage daily
- •Participant has never consumed the test beverage or similar products
- •Participant currently owns a wearable and is willing to use and connect the wearable device
- •Willing to use personal smart phone, tablet, or personal computer with stable internet connection
- •Willing and able to comply with all study procedures
- •Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study
排除标准
- •History or presence, on the basis of the health history, of clinically important condition or disease states
- •Is currently following, or planning to be on, a weight loss regimen
- •Weight loss or gain >4.5 kg
- •History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions
- •History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
- •History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder
- •Use of tobacco/nicotine products
- •Use of hemp/marijuana products
- •Unstable use of any prescription medication
- •Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine
- •Recent history of alcohol or substance abuse
- •Exposed to any non-registered drug product
- •Self-report of hypertension/high blood pressure without use of hypertensive medications
- •Any known allergy or intolerance to any ingredients contained in the study product
- •Any signs or symptoms of active infection of clinical relevance
- •History or presence of cancer, except for non-melanoma skin cancer
- •History of any major trauma or major surgical event
- •Female who is pregnant, planning to be pregnant during the study period, lactating
- •An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.
- •Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol
- •A clinically significant medical condition that is affected by caffeine
研究组 & 干预措施
Test caffeinated beverage followed by participants' typical caffeinated beverage
干预措施: Participants' typical caffeinated beverage (Other)
Test caffeinated beverage followed by participants' typical caffeinated beverage
干预措施: Test caffeinated beverage (Other)
Participants' typical caffeinated beverage followed by test caffeinated beverage
干预措施: Participants' typical caffeinated beverage (Other)
Participants' typical caffeinated beverage followed by test caffeinated beverage
干预措施: Test caffeinated beverage (Other)
结局指标
主要结局
Subjective caffeine visual analog scales
时间窗: After 5 days of daily consumption
Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.
次要结局
- Subjective caffeine visual analog scales(Up to 5 hours after beverage consumption)
- Subjective quality of life ratings(After 5 days of daily consumption)