How different caffeinated drinks affect well-being
A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
We will test whether switching to different caffeinated drinks changes mood, energy, and physical responses in healthy adults who regularly drink sweetened caffeine.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Guayaki Sustainable Rainforest Products, INC. Industry-sponsored |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT07404254 on ClinicalTrials.gov |
What this trial studies
Healthy adults who routinely consume sweetened caffeinated drinks will replace their usual beverage with one of the test drinks (caffeinated low-sugar, caffeinated, or control) and consume it daily. Participants will report subjective caffeine responses using visual analog scale questionnaires plus mood and quality-of-life measures. Wearable devices will collect physiological data to compare how ingredient variations relate to objective responses. The study is conducted at a single site in San Francisco and requires participants to use their own smartphone and wearable to link data.
Who should consider this trial
Good fit: Ideal candidates are generally healthy adults aged 18–55 with BMI between 18.5 and 35 who consistently consume sweetened caffeine, own a wearable, and are willing to substitute their routine with the test beverage and connect their device.
Not a fit: People with important medical conditions, those on or planning weight-loss regimens, people outside the age or BMI ranges, or those who do not regularly drink sweetened caffeine are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the results could help people choose caffeinated drinks that give preferred mood and energy effects while minimizing unwanted physical responses.
How similar studies have performed: Prior research shows caffeine alters alertness and mood, but using wearables to compare ingredient variations in commercial caffeinated beverages is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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
- Email: info@guayaki.com
- Phone: 609-799-6067
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.