Healthy, Caffeine, Beverage Intake
Conditions
Keywords
caffeine beverages in health and well-being
Brief summary
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverage variations in generally healthy adults.
Detailed description
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.
Interventions
OTHERCaffeinated, low sugar beverage
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
OTHERCaffeinated beverage
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
OTHERControl beverage
Participants will consume a caffeinated beverage with the control level of sweetener and caffeine content.
Sponsors
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
Nlumn LLC
Alethios, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
This interventional trial focuses on evaluating the effects of the intervention on health and well-being.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective caffeine visual analog scales | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective caffeine visual analog scales | Up to 5 hours after beverage consumption | 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. |
| Subjective quality of life ratings | Day 5 | Participants will rate how they feel using a Likert scale from 0-5. Where higher score indicate higher frequency in that feeling. |
| Physiological response - Sleep | Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption | Sleep time in hours will be collected on wearable-derived algorithms (Apple Health, Garmin, or Fitbit). |
| Physiological responses - Activity | Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption | Activity in step count will be collected on wearables (Apple Health, Garmin, or Fitbit) via accelerometry. |
Countries
United States
Contacts
CONTACTVP Product Innovation, Guayaki Sustainable Rainforest Products
CONTACTAlethios, Inc.
PRINCIPAL_INVESTIGATORKristin Nieman, PhD
Nlumn LLC
Outcome results
None listed