NCT07404254已完成不适用
A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2026年1月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 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 beverage variations 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 ingredient variations in caffeine beverages.
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 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 <35.0 kg/m2
- •Generally good health
- •Participant currently and consistently has a sweetened 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
Caffeinated, low sugar beverage
Active Comparator
干预措施: Caffeinated, low sugar beverage (Other)
Caffeinated beverage
Active Comparator
干预措施: Caffeinated beverage (Other)
Control beverage
Placebo Comparator
干预措施: Control beverage (Other)
结局指标
主要结局
Subjective caffeine visual analog scales
时间窗: Day 5
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(Day 5)
- Physiological response - Sleep(Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption)
- Physiological responses - Activity(Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption)
研究者
研究点 (1)
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