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Clinical Trials/NCT07357818
NCT07357818
Recruiting
Not Applicable

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

GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.0 sites150 target enrollmentStarted: November 3, 2025Last updated:
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Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
Enrollment
150
OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

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 \<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 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

Investigators

Sponsor
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
Sponsor Class
Industry
Responsible Party
Sponsor

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