HealthyNCT07357818
Effects of Caffeinated Beverages on Well-being
A study testing Participants' typical caffeinated beverage and Test 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 beverages 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?
- Participants' typical caffeinated beverage and Test caffeinated beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2025to 23 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 <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
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- 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
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- 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, Decentralized, Crossover, Open-Label 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 beverages 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 caffeine beverages compared to participants' habitual caffeine beverage intake in generally healthy adults.
- Conditions
- Healthy, Caffeine, Beverage Intake
- Being tested
- Participants' typical caffeinated beverage, Test caffeinated 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.
Participants' typical caffeinated beverageOther
Participants will consume the caffeinated beverage they typically consume.
Test caffeinated beverageOther
Participants will consume a test beverage that contains caffeine.
| Study group | Role | What they receive |
|---|---|---|
| Test caffeinated beverage followed by participants' typical caffeinated beverage | Other | Not described Receives: Other: Participants' typical caffeinated beverage; Other: Test caffeinated beverage |
| Participants' typical caffeinated beverage followed by test caffeinated beverage | Other | Not described Receives: Other: Participants' typical caffeinated beverage; Other: Test caffeinated 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: After 5 days of daily consumption
Secondary outcomes (2)
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: After 5 days of daily consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start3 Nov 2025
- Primary completion23 Mar 2026
- Study completion23 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
- Crossover
- Model description
- This interventional trial focuses on evaluating the effects of the intervention on health and well-being.
- Masking
- None (open label)
- Enrolment
- 126 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
- NCT07357818
- Sponsor's protocol ID
- NL-2502
- Status last verified
- Aug 2026
- First submitted
- 26 Dec 2025
- 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, Decentralized, Crossover, Open-Label Trial to Assess Subjective and Physiological Responses to Consumption of Caffeinated Beverages in Healthy Adults With a Caffeine Routine
- ClinicalTrials.gov ID
- NCT07357818
- Acronym / sponsor ID
- NL-2502
- Conditions
- Healthy, Caffeine, Beverage Intake
- Keywords
- Caffeine beverages in health and well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- GUAYAKI SUSTAINABLE RAINFOREST PRODUCTS, INC.Industry (pharma, biotech, devices)
- Collaborators
- Nlumn LLC, Alethios, Inc.
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 22 Jan 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 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This interventional trial focuses on evaluating the effects of the intervention on health and well-being.
| Arm | Type | Receives |
|---|---|---|
| Test caffeinated beverage followed by participants' typical caffeinated beverage | Other | Other: Participants' typical caffeinated beverage, Other: Test caffeinated beverage |
| Participants' typical caffeinated beverage followed by test caffeinated beverage | Other | Other: Participants' typical caffeinated beverage, Other: Test caffeinated 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 <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
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 |
|---|---|---|
| Participants' typical caffeinated beverageParticipants will consume the caffeinated beverage they typically consume. | Other | Participants' typical caffeinated beverage followed by test caffeinated beverage, Test caffeinated beverage followed by participants' typical caffeinated beverage |
| Test caffeinated beverageParticipants will consume a test beverage that contains caffeine. | Other | Participants' typical caffeinated beverage followed by test caffeinated beverage, Test caffeinated beverage followed by participants' typical caffeinated beverage |
Primary outcome
Subjective caffeine visual analog scales
Time frame: After 5 days of daily consumption
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.
2 secondary outcomes
Subjective caffeine visual analog scales
Time frame: Up to 5 hours after beverage consumption
Subjective quality of life ratings
Time frame: After 5 days of daily 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
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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 Participants' typical caffeinated beverage and Test 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. 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: After 5 days of daily consumption). 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.