A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
| Registry | NCT07404254 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, other |
| Enrollment | 75 (Actual) |
| Sponsor | GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. (Industry); collaborators: Nlumn LLC, Alethios, Inc. |
| Conditions | Healthy, Caffeine, Beverage Intake |
| Interventions | Caffeinated, low sugar beverage, Caffeinated beverage, Control beverage (Other) |
| Dates | start 2026-01-05, primary completion 2026-03-31, completion 2026-03-31, first posted 2026-02-11, last updated 2026-08-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials for Caffeine All trials of Caffeinated, low sugar beverage All trials of Caffeinated beverage
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverage variations in generally healthy adults.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Caffeinated, low sugar beverage | Active comparator | Other: Caffeinated, low sugar beverage | |
| Caffeinated beverage | Active comparator | Other: Caffeinated beverage | |
| Control beverage | Placebo comparator | Other: Control beverage |
Sex: All, ages: 18 Years to 55 Years, accepts healthy volunteers
Inclusion Criteria: 1. Males or females, ≥18 to ≤55 years of age 2. BMI ≥18.5 and <35.0 kg/m2 3. Generally good health 4. Participant currently and consistently has a sweetened 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
| Facility | City | Country | Status |
|---|---|---|---|
| Alethios, Inc. | San Francisco, California | United States |