RecruitingNot ApplicableNCT07357818

Effects of Caffeinated Beverages on Well-being

A Randomized, Decentralized, Crossover, Open-Label Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine

Sponsor

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.

Enrollment

150 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Healthy Caffeine Beverage Intake

Summary

This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria10

Males or females, ≥18 to ≤55 years of age
BMI ≥18.5 and \<29.9 kg/m2
Generally good health
Participant currently and consistently has a 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 Criteria21

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
History or presence of cancer, except for non-melanoma skin cancer
History of any major trauma or major surgical event
Female who is pregnant, planning to be pregnant during the study period, lactating
An employee, close relative of an employee, or participant who has a financial interest in Sponsor company or any other caffeine beverage company.
Any condition the Investigator believes would interfere with the participant's ability to provide informed consent or comply with the study protocol
A clinically significant medical condition that is affected by caffeine