Effects of Variations in Caffeinated Beverages on 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
1 other identifier
interventional
75
1 country
1
Brief Summary
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverage variations in generally healthy adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable healthy
Started Jan 2026
Shorter than P25 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 5, 2026
CompletedFirst Submitted
Initial submission to the registry
January 12, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedFebruary 11, 2026
February 1, 2025
3 months
January 12, 2026
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective caffeine visual analog scales
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.
Day 5
Secondary Outcomes (4)
Subjective caffeine visual analog scales
Up to 5 hours after beverage consumption
Subjective quality of life ratings
Day 5
Physiological response - Sleep
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Physiological responses - Activity
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Other Outcomes (2)
Physiological responses - Heart rate
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Subjective beverage experience ratings
Day 5
Study Arms (3)
Caffeinated, low sugar beverage
ACTIVE COMPARATORCaffeinated beverage
ACTIVE COMPARATORControl beverage
PLACEBO COMPARATORInterventions
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Participants will consume a caffeinated beverage with the control level of sweetener and caffeine content.
Eligibility Criteria
You may qualify if:
- Males or females, ≥18 to ≤55 years of age
- BMI ≥18.5 and \<35.0 kg/m2
- Generally good health
- Participant currently and consistently has a sweetened caffeine routine
- Participant is willing to substitute their current caffeine routine for the test beverage daily
- Participant has never consumed the test beverage or similar products
- Participant currently owns a wearable and is willing to use and connect the wearable device
- Willing to use personal smart phone, tablet, or personal computer with stable internet connection
- Willing and able to comply with all study procedures
- Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study
You may not qualify if:
- History or presence, on the basis of the health history, of clinically important condition or disease states
- Is currently following, or planning to be on, a weight loss regimen
- Weight loss or gain \>4.5 kg
- History of gastrointestinal surgery for weight reducing purposes or gastrointestinal (GI) conditions
- History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
- History of unconventional sleep patterns (e.g., night shift) or diagnosed sleep disorder
- Use of tobacco/nicotine products
- Use of hemp/marijuana products
- Unstable use of any prescription medication
- Use of any medications(s) or dietary supplement(s), containing caffeine, or interacting with caffeine
- Recent history of alcohol or substance abuse
- Exposed to any non-registered drug product
- Self-report of hypertension/high blood pressure without use of hypertensive medications
- Any known allergy or intolerance to any ingredients contained in the study product
- Any signs or symptoms of active infection of clinical relevance
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.lead
- Nlumn LLCcollaborator
- Alethios, Inc.collaborator
Study Sites (1)
Alethios, Inc.
San Francisco, California, 94109, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Nieman, PhD
Nlumn LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2026
First Posted
February 11, 2026
Study Start
January 5, 2026
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
February 11, 2026
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share