AlertnessPhase 1NCT05096780
Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
A Phase 1 study testing Flavored caffeinated beverage in people with Alertness, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alertness
- What is being tested?
- Flavored caffeinated beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 6 Feb 2022
- Phase
- Phase 1
- 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
- Healthy adult male and female volunteers aged 18 to 55 years
- Have a BMI of 18 to 32.49 kg/m2 (inclusive)
- Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)
- Willing to commit to 4 long test days (~15-16 hrs)
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
- Willing to avoid caffeine-containing products for ≥48 hrs prior to visits and until the completion of each test visit
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- Willing to avoid alcohol for ≥24 hrs prior to visits
- Willing to fast 10 hrs prior to visits
- Willing to stick to their usual dietary patterns and avoid grapefruit
- Willing to stick to their usual physical activity level throughout the study
- Willing to stick to their usual sleep pattern
- No participation in any clinical trial within the past 30 days and throughout this study, or any PEP protocol within the past 6 months
Who cannot join
- Subjects will be excluded from the study if they have:
- Reported history or clinical manifestations of significant metabolic (including type1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders unless deemed clinically not significant by investigator
- Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
- Current clinically significant viral infection
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Are pregnant or breastfeeding or planning to become pregnant
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- Resting heart rate less than 45 bpm or greater than 100 bpm
- History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure greater than or equal to 50/90 mm Hg)
- History of significant surgery that may affect absorption of caffeine. Appendectomy and/or cholecystectomy will be allowed
- Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis)
- Extreme dietary habits, including but not limited to intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic
- History of alcoholism or drug addiction within 1 year prior to Screening, or current alcohol or drug use that, in the opinion of the investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations
- One or more tobacco-containing or nicotine-containing product occasions per month on average, or use of such products within 48 hours prior to dosing of each study period
- Use of any prescription or nonprescription drugs (including vitamins, minerals, and phytotherapeutic, herbal, or plant-derived preparations) is prohibited within 7 days prior to the dose of study product, unless deemed acceptable by the Investigator
- Use of any medication known to have an interaction with caffeine including oral contraceptives (e.g., medications metabolized via the CYP1A2 pathway)
- Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening
- Receipt of blood products within 3 months prior to study entry
- Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks.
The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.
- Conditions
- Alertness
- Being tested
- Flavored caffeinated beverage
- Keywords
- caffeine, beverage, energy, mood, encapsulated, Caffeine Research VAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flavored caffeinated beverageOther
16.9 oz (500 cc), carbonated, zero calorie
| Study group | Role | What they receive |
|---|---|---|
| Beverage 1 | Active comparator | Free caffeine 160 mg Receives: Other: Flavored caffeinated beverage |
| Beverage 2 | Experimental | Encapsulated caffeine 160 mg Receives: Other: Flavored caffeinated beverage |
| Beverage 3 | Active comparator | Free caffeine 250 mg Receives: Other: Flavored caffeinated beverage |
| Beverage 4 | Experimental | Encapsulated caffeine 250 mg Receives: Other: Flavored caffeinated beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alertness
A self-reported mood measurement from the Caffeine Research Visual Analog Scale (VAS) rated from 0 (not at all) to 100 mm (extremely alert), to compare dose-matched free caffeine to encapsulated caffeine. Longer-lasting alertness would be a benefit.
Measured: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
Plasma caffeine PK profile of (AUC0-t, AUC0-inf)
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine (AUC0-t, AUC0-inf)
Measured: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma caffeine PK profile of peak caffeine concentration (Cmax)
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine peak caffeine concentration (Cmax)
Measured: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma caffeine PK profile of time to maximal plasma caffeine concentration (Tmax)
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine time to maximal plasma caffeine concentration (Tmax)
Measured: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma caffeine PK profile of half-life (t1/2)
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine half-life (t1/2)
Measured: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma caffeine PK profile of plasma caffeine concentration by time
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine concentration by time
Measured: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Secondary outcomes (4)
The 6 other Caffeine Research Visual Analog Scale (VAS) symptom ratings besides alertness
Self-reported Caffeine Research Visual Analog Scale (VAS) ratings from 0-100 mm representing the full range of each dimension (relaxed, jittery, tired, tense, headache, overall mood) to compare dose-matched free caffeine to encapsulated caffeine. More relaxed, less jittery, less tired, less tense, no headache and better mood would be better.
Measured: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
3 additional other symptoms Visual Analog Scale (VAS) ratings
Self-reported caffeine symptoms (lightheaded, irritable, pounding heartbeat) rated on a Visual Analog Scale (VAS) from 0 (not at all) to 100 mm (extremely) to compare dose-matched free caffeine to encapsulated caffeine. Absence of these would be better.
Measured: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
Blood pressure
Vital sign for safety monitoring. Resting blood pressures within normal limits would be better.
Measured: Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion
Heart rate
Vital sign for safety monitoring. Resting heart rates within normal limits would be better.
Measured: Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start8 Oct 2021
- Primary completion6 Feb 2022
- Study completion6 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlertnessStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Swarna Yadlapalli, MD, Principal investigator, Medical Director, Axis Clinicals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096780
- Sponsor's protocol ID
- PEP-2110
- Status last verified
- Mar 2022
- First submitted
- 15 Oct 2021
- Last updated
- 24 Mar 2022
- 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 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage and Associated Mood and Physiological Effects
- ClinicalTrials.gov ID
- NCT05096780
- Acronym / sponsor ID
- PEP-2110
- Conditions
- Alertness
- Keywords
- caffeine, beverage, energy, mood, encapsulated, Caffeine Research VAS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 27 Oct 2021 (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 is designed to compare self-reported mood states for encapsulated caffeine compared to dose-matched free caffeine, when consumed as a ready-to-drink beverage in healthy subjects. Additionally, this study will characterize the plasma caffeine pharmacokinetic profile for the encapsulated and free caffeine beverages. Two different caffeine levels, 160 and 250 mg will be included, which represent more common caffeine consumption from typical energy drinks.
The primary outcomes are alertness ratings from the Caffeine Research visual analog scale (VAS) and PK parameters over 12 hours. Secondary outcomes are Caffeine Research VAS scores (beyond alertness), three other symptom VAS scores, and vital signs for safety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beverage 1 | Active comparator | Other: Flavored caffeinated beverageFree caffeine 160 mg |
| Beverage 2 | Experimental | Other: Flavored caffeinated beverageEncapsulated caffeine 160 mg |
| Beverage 3 | Active comparator | Other: Flavored caffeinated beverageFree caffeine 250 mg |
| Beverage 4 | Experimental | Other: Flavored caffeinated beverageEncapsulated caffeine 250 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult male and female volunteers aged 18 to 55 years
- Have a BMI of 18 to 32.49 kg/m2 (inclusive)
- Are regular caffeine consumers (average 1 to 3 caffeine-containing beverages per day, not to exceed 400 mg/ per day)
- Willing to commit to 4 long test days (~15-16 hrs)
- Able to comprehend and willing to sign an Informed Consent Form (ICF)
Key exclusion criteria (18 listed)
- Reported history or clinical manifestations of significant metabolic (including type1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders unless deemed clinically not significant by investigator
- Current or recent history (<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
- Current clinically significant viral infection
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Are pregnant or breastfeeding or planning to become pregnant
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 |
|---|---|---|
| Flavored caffeinated beverage16.9 oz (500 cc), carbonated, zero calorie | Other | Beverage 1, Beverage 2, Beverage 3, Beverage 4 |
Primary outcome
Alertness
Time frame: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
A self-reported mood measurement from the Caffeine Research Visual Analog Scale (VAS) rated from 0 (not at all) to 100 mm (extremely alert), to compare dose-matched free caffeine to encapsulated caffeine. Longer-lasting alertness would be a benefit.
Plasma caffeine PK profile of (AUC0-t, AUC0-inf)
Time frame: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine (AUC0-t, AUC0-inf)
Plasma caffeine PK profile of peak caffeine concentration (Cmax)
Time frame: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine peak caffeine concentration (Cmax)
Plasma caffeine PK profile of time to maximal plasma caffeine concentration (Tmax)
Time frame: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine time to maximal plasma caffeine concentration (Tmax)
Plasma caffeine PK profile of half-life (t1/2)
Time frame: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine half-life (t1/2)
Plasma caffeine PK profile of plasma caffeine concentration by time
Time frame: Changes from pre-dose baseline to 12 hours after the first sip of beverage.
Plasma sampling at 19 time points: Pre-dose baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11 and 12 hours post first sip of beverage ingestion to characterize dose-matched free caffeine compared to encapsulated caffeine for plasma caffeine concentration by time
4 secondary outcomes
The 6 other Caffeine Research Visual Analog Scale (VAS) symptom ratings besides alertness
Time frame: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
3 additional other symptoms Visual Analog Scale (VAS) ratings
Time frame: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion
Blood pressure
Time frame: Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion
Heart rate
Time frame: Changes from pre-dose baseline to 2 and 6 hours post beverage ingestion
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 24 Mar 2022.
- 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.
Swarna Yadlapalli, MD principal investigator
Medical Director, Axis Clinicals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Flavored caffeinated beverage in people with Alertness, run by PepsiCo Global R&D 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 12 inclusion and 18 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 24 Mar 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Alertness (time frame: Changes from pre-dose baseline to 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post beverage ingestion). The study lists 6 primary outcomes in all. 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 24 Mar 2022.