Actively Recruiting
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
Led by GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. · Updated on 2026-01-22
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
G
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
Lead Sponsor
N
Nlumn LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how generally healthy adults with a regular caffeine routine respond subjectively and physiologically to caffeinated beverages. The study compares reactions to a test caffeinated beverage with participants' usual caffeine intake to understand effects on mood, quality of life, and caffeine-related sensations. Participants will consume either their typical caffeinated beverage or a test caffeinated beverage in a randomized crossover design. They will substitute their usual caffeine drink with the test beverage daily during the study periods. This open-label trial does not use blinding and involves daily beverage consumption over defined phases. During the study, participants will complete visual analog scale questionnaires assessing subjective caffeine responses and quality of life after five days of daily consumption. Physiological responses will also be monitored using wearable devices connected to participants' smartphones or computers. The primary outcome is subjective caffeine response after five days, with additional assessments up to five hours post-consumption. The total participation period extends through the study's consumption and monitoring phases.
CONDITIONS
Brief Title
Effects of Caffeinated Beverages on Well-being
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females, 18 to 55 years of age
- Body mass index (BMI) between 18.5 and less than 29.9 kg/m2
- Generally good health
- Currently and consistently has a caffeine routine
- Willing to substitute current caffeine routine for the test beverage daily
- Has never consumed the test beverage or similar products
- Currently owns a wearable device and willing to use and connect it
- Willing to use personal smartphone, tablet, or computer with stable internet
- Willing and able to comply with all study procedures
- Willing to adhere to study procedures and provide informed consent
You will not qualify if you...
- History or presence of clinically important conditions or diseases
- Currently following or planning to be on a weight loss regimen
- Weight loss or gain greater than 4.5 kg
- History of gastrointestinal surgery for weight loss or gastrointestinal conditions
- History of eating disorders such as anorexia nervosa, bulimia nervosa, or binge eating
- History of unconventional sleep patterns or diagnosed sleep disorder
- Use of tobacco or nicotine products
- Use of hemp or marijuana products
- Unstable use of any prescription medication
- Use of medications or supplements containing caffeine or interacting with caffeine
- Recent alcohol or substance abuse
- Exposure to any non-registered drug product
- Self-reported hypertension without use of hypertensive medications
- Known allergy or intolerance to any ingredients in the study product
- Signs or symptoms of active infection of clinical relevance
- History or presence of cancer except non-melanoma skin cancer
- History of major trauma or major surgery
- Female who is pregnant, planning pregnancy, or lactating
- Employee, close relative, or participant with financial interest in sponsor or caffeine beverage companies
- Any condition that interferes with informed consent or study compliance
- Clinically significant medical condition affected by caffeine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote or in-person)
Duration - 5 days
Participants consume the test caffeinated beverage daily and complete subjective and physiological assessments.
Daily remote assessments and continuous wearable device monitoring
Duration - 5 days
Participants consume their typical caffeinated beverage daily and complete similar assessments for comparison.
Daily remote assessments and continuous wearable device monitoring
Trial Site Locations
Total: 1 location
1
Alethios, Inc.
San Francisco, California, United States, 94109
Actively Recruiting
Research Team
V
VP Product Innovation, Guayaki Sustainable Rainforest Products
A
Alethios, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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