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CompletedNCT04281758Updated Oct 30, 2020

Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers

A Phase 1 interventional study of Beverage in Plasma Caffeine Concentration, sponsored by PepsiCo Global R&D. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-30.

Sponsored by PepsiCo Global R&D · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Plasma Caffeine Concentration

Keywords

  • caffeine
  • botanicals
  • beverage
  • mood
03

In context

Lead sponsor

PepsiCo Global R&D is the lead sponsor of 101 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy adult male volunteers aged 18 to 55 years.
  2. Have a BMI of 18 to 29 kg/m2 (inclusive)
  3. Able to comprehend and willing to sign an Informed Consent Form (ICF).
  4. Willing to avoid caffeine for ≥48 hrs prior to visits
  5. Willing to avoid alcohol for ≥24 hrs prior to visits
  6. Willing to fast 10 hrs prior to visits
  7. Willing to stick to their usual dietary patterns
  8. Willing to stick to their usual physical activity level throughout the study
  9. No participation in any clinical trial within the past 30 days or any PEP protocol within the past 6 months.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Current or recent history (\<30 days prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
  3. Current clinically significant viral infection
  4. History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
  5. Resting heart rate less than 45 bpm or greater than 100 bpm.
  6. History of unstable ischemic heart disease or uncontrolled hypertension (blood pressure greater than or equal to 150/90 mm Hg)
  7. History of stomach or intestinal surgery, except that appendectomy and/or cholecystectomy will be allowed.
  8. Presence of a malabsorption syndrome possibly affecting drug/Product absorption (e.g., Crohn's disease or chronic pancreatitis).
  9. Extreme dietary habits, including but not limited to vegetarian diets and intentional consumption of a high fiber diet, gluten-free, low-carb, vegan, ketogenic.
  10. 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.
  11. 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.
  12. 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.
  13. Use of alcohol-containing within 24 hours prior to study entry.
  14. Use of caffeine containing products 48 hours prior to each dose of study product and during each dosing day.
  15. Donation of blood in excess of 500 ml within 4 weeks prior to study entry or of plasma within 2 weeks prior to Screening.
  16. Receipt of blood products within 3 months prior to study entry.
  17. Subjects who, in the opinion of the investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    Caffeine beverage (control)

    Flavored still beverage with caffeine 100 mg

    Other: Beverage

  • Experimental
    Caffeine beverage plus bioactive 1

    Flavored still beverage with caffeine 100 mg + quercetin 250 mg

    Other: Beverage

  • Experimental
    Caffeine beverage plus bioactive 2

    Flavored still beverage with caffeine 100 mg + curcumin 80 mg

    Other: Beverage

  • Experimental
    Caffeine beverage plus bioactive 3

    Flavored still beverage with caffeine 100 mg + methylliberine 75 mg

    Other: Beverage

Interventions

  • OtherBeverage

    16 oz (473.2 ml)

06

What researchers measure

Primary outcomes

  1. Incremental area-under-the-concentration-curve (iAUC)

    Plasma caffeine level

    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

Secondary outcomes

  1. Caffeine concentration

    Plasma caffeine level

    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

  2. Peak caffeine concentration (Cmax)

    Plasma caffeine level

    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

  3. Time to maximum concentration (Tmax)

    Plasma caffeine level

    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

  4. Return to baseline concentration (TBR)

    Plasma caffeine level

    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

  5. 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.

    Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose

  6. Bond-Lader Mood

    VAS scale,16 terms, each rated on a 100 mm line. Example, relaxed is better than tense.

    Time frame: At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose

07

Study locations

1 site
  • Prism Clinical Research
    Saint Paul, Minnesota 55114, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04281758
Lead sponsor
PepsiCo Global R&D
Responsible party
Sponsor
First posted
Feb 24, 2020
Start date
Jul 20, 2020
Primary completion
Oct 1, 2020
Completion
Oct 13, 2020
Last update
Oct 30, 2020

Study contacts

Trisha R Shamp, PhD
principal investigator · Prism Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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