HealthyNCT07404254
Effects of Variations in Caffeinated Beverages on Well-being
A study testing Caffeinated, low sugar beverage and Caffeinated beverage in people with Healthy and Caffeine, run by GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. at 1 site in United States.
Trial summary
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverage variations in generally healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Caffeine, Beverage Intake
- What is being tested?
- Caffeinated, low sugar beverage and Caffeinated beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
This study will evaluate post-beverage subjective caffeine responses and physiological responses to caffeinated beverage variations in generally healthy adults.
Read the 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.
- Conditions
- Healthy, Caffeine, Beverage Intake
- Being tested
- Caffeinated, low sugar beverage, Caffeinated beverage, Control beverage
- Keywords
- caffeine beverages in health and well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeinated, low sugar beverageOther
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Caffeinated beverageOther
Participants will consume a caffeinated beverage with variations in sweetener and caffeine content.
Control beverageOther
Participants will consume a caffeinated beverage with the control level of sweetener and caffeine content.
| Study group | Role | What they receive |
|---|---|---|
| Caffeinated, low sugar beverage | Active comparator | Not described Receives: Other: Caffeinated, low sugar beverage |
| Caffeinated beverage | Active comparator | Not described Receives: Other: Caffeinated beverage |
| Control beverage | Placebo comparator | Not described Receives: Other: Control beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5
Secondary outcomes (4)
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.
Measured: Up to 5 hours after beverage consumption
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.
Measured: Day 5
Physiological response - Sleep
Sleep time in hours will be collected on wearable-derived algorithms (Apple Health, Garmin, or Fitbit).
Measured: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Physiological responses - Activity
Activity in step count will be collected on wearables (Apple Health, Garmin, or Fitbit) via accelerometry.
Measured: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start5 Jan 2026
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This interventional trial focuses on evaluating the effects of the intervention on health and well-being.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nlumn LLC, Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Kristin Nieman, PhD, Principal investigator, Nlumn LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404254
- Sponsor's protocol ID
- NL-2503
- Status last verified
- Aug 2026
- First submitted
- 12 Jan 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
- ClinicalTrials.gov ID
- NCT07404254
- Acronym / sponsor ID
- NL-2503
- Conditions
- Healthy, Caffeine, Beverage Intake
- Keywords
- caffeine beverages in health and well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.Industry (pharma, biotech, devices)
- Collaborators
- Nlumn LLC, Alethios, Inc.
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This interventional trial focuses on evaluating the effects of the intervention on health and well-being.
| Arm | Type | Receives |
|---|---|---|
| Caffeinated, low sugar beverage | Active comparator | Other: Caffeinated, low sugar beverage |
| Caffeinated beverage | Active comparator | Other: Caffeinated beverage |
| Control beverage | Placebo comparator | Other: Control beverage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeinated, low sugar beverageParticipants will consume a caffeinated beverage with variations in sweetener and caffeine content. | Other | Caffeinated, low sugar beverage |
| Caffeinated beverageParticipants will consume a caffeinated beverage with variations in sweetener and caffeine content. | Other | Caffeinated beverage |
| Control beverageParticipants will consume a caffeinated beverage with the control level of sweetener and caffeine content. | Other | Control beverage |
Primary outcome
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.
4 secondary outcomes
Subjective caffeine visual analog scales
Time frame: Up to 5 hours after beverage consumption
Subjective quality of life ratings
Time frame: Day 5
Physiological response - Sleep
Time frame: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Physiological responses - Activity
Time frame: Up to 5 hours post-beverage consumption and after 5 days of daily beverage consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Nieman, PhD principal investigator
Nlumn LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeinated, low sugar beverage and Caffeinated beverage in people with Healthy and Caffeine, run by GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective caffeine visual analog scales (time frame: Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.