Plasma Caffeine ConcentrationPhase 1NCT04281758
Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
A Phase 1 study testing Beverage in people with Plasma Caffeine Concentration, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
This is a Phase 1, double blind, randomized, controlled, cross-over trial. The primary outcome is to quantify the incremental area-under-the-concentration-curve (iAUC) for plasma caffeine after oral consumption of caffeinated beverages with various bioactive compounds vs. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plasma Caffeine Concentration
- What is being tested?
- Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2020to 13 Oct 2020
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult male volunteers aged 18 to 55 years.
- Have a BMI of 18 to 29 kg/m2 (inclusive)
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Willing to avoid caffeine for ≥48 hrs prior to visits
- Willing to avoid alcohol for ≥24 hrs prior to visits
- Willing to fast 10 hrs prior to visits
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- Willing to stick to their usual dietary patterns
- Willing to stick to their usual physical activity level throughout the study
- No participation in any clinical trial within the past 30 days or any PEP protocol within the past 6 months.
Who cannot join
- Reported history or clinical manifestations of significant metabolic (including type 1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
- 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
- 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 150/90 mm Hg)
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- History of stomach or intestinal surgery, except that 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 vegetarian diets and 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.
- Use of any tobacco-containing or nicotine-containing products (including cigarette, pipe, cigar, chewing tobacco, nicotine patch, or nicotine gum and vaping products) within 2 months prior to study entry.
- 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 alcohol-containing within 24 hours prior to study entry.
- Use of caffeine containing products 48 hours prior to each dose of study product and during each dosing day.
- 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.
United States1 site
Prism Clinical Research
Saint Paul, Minnesota, 55114
About this study
This is a Phase 1, double blind, randomized, controlled, cross-over trial.
The primary outcome is to quantify the incremental area-under-the-concentration-curve (iAUC) for plasma caffeine after oral consumption of caffeinated beverages with various bioactive compounds vs. caffeine alone, in 16 healthy volunteers
Read more
Secondary outcomes are caffeine concentration at each time point from pre-dose baseline to 3.5 hrs post-dose, peak caffeine concentration (Cmax), time to maximum caffeine concentration (Tmax) and return to baseline concentration (TBR) for plasma caffeine
Other outcomes are ratings of physiological symptoms and mood, assessed using visual analog scales (VAS).
Polyphenol food frequency questionnaire data at screening will be collected as a possible co-variate.
- Conditions
- Plasma Caffeine Concentration
- Being tested
- Beverage
- Keywords
- caffeine, botanicals, beverage, mood
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeverageOther
16 oz (473.2 ml)
| Study group | Role | What they receive |
|---|---|---|
| Caffeine beverage (control) | Active comparator | Flavored still beverage with caffeine 100 mg Receives: Other: Beverage |
| Caffeine beverage plus bioactive 1 | Experimental | Flavored still beverage with caffeine 100 mg + quercetin 250 mg Receives: Other: Beverage |
| Caffeine beverage plus bioactive 2 | Experimental | Flavored still beverage with caffeine 100 mg + curcumin 80 mg Receives: Other: Beverage |
| Caffeine beverage plus bioactive 3 | Experimental | Flavored still beverage with caffeine 100 mg + methylliberine 75 mg Receives: Other: Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental area-under-the-concentration-curve (iAUC)
Plasma caffeine level
Measured: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Secondary outcomes (6)
Caffeine concentration
Plasma caffeine level
Measured: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Peak caffeine concentration (Cmax)
Plasma caffeine level
Measured: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Time to maximum concentration (Tmax)
Plasma caffeine level
Measured: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Return to baseline concentration (TBR)
Plasma caffeine level
Measured: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Physiological Symptoms
VAS scale, 9 terms, each rated on a 100 mm line from "Not at all" to "Extremely'. Example, not at all irritable is better than extremely irritable.
Measured: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
Bond-Lader Mood
VAS scale,16 terms, each rated on a 100 mm line. Example, relaxed is better than tense.
Measured: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start20 Jul 2020
- Primary completion1 Oct 2020
- Study completion13 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasma Caffeine ConcentrationStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trisha R Shamp, PhD, Principal investigator, Prism Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281758
- Sponsor's protocol ID
- PEP-1913
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2020
- Last updated
- 30 Oct 2020
- 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 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04281758
- Acronym / sponsor ID
- PEP-1913
- Conditions
- Plasma Caffeine Concentration
- Keywords
- caffeine, botanicals, beverage, mood
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 13 Oct 2020 (actual)
- First posted
- 24 Feb 2020 (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 is a Phase 1, double blind, randomized, controlled, cross-over trial.
The primary outcome is to quantify the incremental area-under-the-concentration-curve (iAUC) for plasma caffeine after oral consumption of caffeinated beverages with various bioactive compounds vs. caffeine alone, in 16 healthy volunteers
Secondary outcomes are caffeine concentration at each time point from pre-dose baseline to 3.5 hrs post-dose, peak caffeine concentration (Cmax), time to maximum caffeine concentration (Tmax) and return to baseline concentration (TBR) for plasma caffeine
Other outcomes are ratings of physiological symptoms and mood, assessed using visual analog scales (VAS).
Polyphenol food frequency questionnaire data at screening will be collected as a possible co-variate.
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 |
|---|---|---|
| Caffeine beverage (control) | Active comparator | Other: BeverageFlavored still beverage with caffeine 100 mg |
| Caffeine beverage plus bioactive 1 | Experimental | Other: BeverageFlavored still beverage with caffeine 100 mg + quercetin 250 mg |
| Caffeine beverage plus bioactive 2 | Experimental | Other: BeverageFlavored still beverage with caffeine 100 mg + curcumin 80 mg |
| Caffeine beverage plus bioactive 3 | Experimental | Other: BeverageFlavored still beverage with caffeine 100 mg + methylliberine 75 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy adult male volunteers aged 18 to 55 years.
- Have a BMI of 18 to 29 kg/m2 (inclusive)
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Willing to avoid caffeine for ≥48 hrs prior to visits
- Willing to avoid alcohol for ≥24 hrs prior to visits
Key exclusion criteria (17 listed)
- Reported history or clinical manifestations of significant metabolic (including type 1 or type 2 diabetes mellitus), hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological, or psychiatric disorders.
- 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
- Resting heart rate less than 45 bpm or greater than 100 bpm.
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 |
|---|---|---|
| Beverage16 oz (473.2 ml) | Other | Caffeine beverage (control), Caffeine beverage plus bioactive 1, Caffeine beverage plus bioactive 2, Caffeine beverage plus bioactive 3 |
Primary outcome
Incremental area-under-the-concentration-curve (iAUC)
Time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Plasma caffeine level
6 secondary outcomes
Caffeine concentration
Time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Peak caffeine concentration (Cmax)
Time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Time to maximum concentration (Tmax)
Time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Return to baseline concentration (TBR)
Time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose
Physiological Symptoms
Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
Bond-Lader Mood
Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose
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 30 Oct 2020.
- Individual participant dataSharing planned: No
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.
Trisha R Shamp, PhD principal investigator
Prism Clinical Research
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 Beverage in people with Plasma Caffeine Concentration, 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 9 inclusion and 17 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 30 Oct 2020. 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?
Incremental area-under-the-concentration-curve (iAUC) (time frame: At each of 4 testing days, -30 and 0 min pre-dose, and 15, 30, 45, 60, 90, 120, 150, 180 and 210 minutes post-dose). 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 30 Oct 2020.