How caffeinated drinks affect well-being

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

This trial will test whether switching to a specific caffeinated beverage changes how generally healthy adults feel and their physiological responses.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. (industry)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07357818 on ClinicalTrials.gov

What this trial studies

Generally healthy adults who regularly consume caffeine will replace their usual caffeinated drink with a provided test beverage for a defined period while continuing normal routines. Subjective effects will be measured with visual analog scale questionnaires covering mood and quality of life, and physiological responses will be captured via participants' wearable devices. The responses to the test beverage will be compared to participants' habitual caffeine intake to identify any differences in subjective and objective measures. Participants must meet age and BMI criteria, own a wearable, and be willing to use internet-connected personal devices for data collection.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults aged 18–55 with BMI 18.5–29.9 who have a consistent caffeine routine, can substitute their usual beverage with the test product, and can use a wearable plus an internet-connected device.

Not a fit: People with clinically important medical conditions, those on or planning weight-loss regimens, individuals with recent large weight changes, or those outside the specified age or BMI ranges are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the results could help people choose caffeinated beverages that better support mood and day-to-day well-being.

How similar studies have performed: Prior research shows caffeine can acutely alter alertness, mood, and physiological measures, but direct comparisons of specific commercial caffeinated beverages in generally healthy adults are relatively limited.

Eligibility criteria

Inclusion Criteria:

1. Males or females, ≥18 to ≤55 years of age
2. BMI ≥18.5 and \<29.9 kg/m2
3. Generally good health
4. Participant currently and consistently has a caffeine routine
5. Participant is willing to substitute their current caffeine routine for the test beverage daily
6. Participant has never consumed the test beverage or similar products
7. Participant currently owns a wearable and is willing to use and connect the wearable device
8. Willing to use personal smart phone, tablet, or personal computer with stable internet connection
9. Willing and able to comply with all study procedures
10. Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study

Exclusion Criteria:

1. History or presence, on the basis of the health history, of clinically important condition or disease states
2. Is currently following, or planning to be on, a weight loss regimen
3. Weight loss or gain \>4.5 kg
4. History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions
5. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
6. History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder
7. Use of tobacco/nicotine products
8. Use of hemp/marijuana products
9. Unstable use of any prescription medication
10. Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine
11. Recent history of alcohol or substance abuse
12. Exposed to any non-registered drug product
13. Self-report of hypertension/high blood pressure without use of hypertensive medications
14. Any known allergy or intolerance to any ingredients contained in the study product
15. Any signs or symptoms of active infection of clinical relevance
16. History or presence of cancer, except for non-melanoma skin cancer
17. History of any major trauma or major surgical event
18. Female who is pregnant, planning to be pregnant during the study period, lactating
19. An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.
20. Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol
21. A clinically significant medical condition that is affected by caffeine

Where this trial is running

San Francisco, California

• Alethios, Inc. — San Francisco, California, United States (RECRUITING)

Study contacts

• Principal investigator: Kristin Nieman, PhD — Nlumn LLC
• Study coordinator: VP Product Innovation, Guayaki Sustainable Rainforest Products

Conditions: Healthy, Caffeine, Beverage Intake, Caffeine beverages in health and well-being