Effects of Caffeinated Beverages on Well-being
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
About this trial
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverages in generally healthy adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Participants' typical caffeinated beverage
Other interventionParticipants will consume the caffeinated beverage they typically consume.
Test caffeinated beverage
Other interventionParticipants will consume a test beverage that contains caffeine.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Test caffeinated beverage followed by participants' typical caffeinated beverageOther 2 interventions
Group B: Participants' typical caffeinated beverage followed by test caffeinated beverageOther 2 interventions
Trial outcomes
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.
Time frame
After 5 days of daily consumptionSecondary 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.
Time frame
Up to 5 hours after beverage consumption2
Subjective quality of life ratings
Participants will rate how they feel using a Likert scale from 0-5. Where higher score indicate higher frequency in that feeling.
Time frame
After 5 days of daily consumptionOther outcomes
1
Physiological responses - Heart rate
Data collected by wearables
Time frame
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption2
Subjective beverage experience ratings
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.
Time frame
After 5 days of daily consumption3
Physiological response - Sleep
Data collected by wearables
Time frame
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption4
Physiological responses - Activity
Data collected by wearables
Time frame
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumptionSponsors and contacts
Click on the lead sponsor to view all of their trials.
GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
Lead sponsor
Nlumn LLC
Collaborator
Alethios, Inc.
Collaborator
Source ClinicalTrials.gov