Effects of Variations in 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 beverage variations in generally healthy adults.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
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
Parallel
Treatments tested in this trial
Caffeinated, low sugar beverage
Other interventionParticipants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Caffeinated beverage
Other interventionParticipants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Control beverage
Other interventionParticipants will consume a caffeinated beverage with the control level of sweetener and caffeine content.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Caffeinated, low sugar beverageActive comparator 1 intervention
Group B: Caffeinated beverageActive comparator 1 intervention
Group C: Control beveragePlacebo comparator 1 intervention
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
Day 5Secondary 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
Day 53
Physiological response - Sleep
Sleep time in hours will be collected on wearable-derived algorithms (Apple Health, Garmin, or Fitbit).
Time frame
Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption4
Physiological responses - Activity
Activity in step count will be collected on wearables (Apple Health, Garmin, or Fitbit) via accelerometry.
Time frame
Up to 5 hours post-beverage consumption and after 5 days of daily beverage 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
Day 5Sponsors 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