NCT07404254
Recruiting
Not Applicable
A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.1 site in 1 country75 target enrollmentStarted: January 5, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Subjective caffeine visual analog scales
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control beverage
Placebo Comparator
Intervention: Control beverage (Other)
Caffeinated, low sugar beverage
Active Comparator
Intervention: Caffeinated, low sugar beverage (Other)
Caffeinated beverage
Active Comparator
Intervention: Caffeinated beverage (Other)
Outcomes
Primary Outcomes
Subjective caffeine visual analog scales
Time Frame: 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 Outcomes
- 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)
Investigators
Study Sites (1)
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