MedTrace Logo

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

NCT04281758 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2020-10-30

No results posted yet for this 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.

Conditions

  • Plasma Caffeine Concentration

Interventions

OTHER

Beverage

16 oz (473.2 ml)

Sponsors & Collaborators

  • PepsiCo Global R&D

    lead INDUSTRY

Principal Investigators

  • Trisha R Shamp, PhD · Prism Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-20
Primary Completion
2020-10-01
Completion
2020-10-13

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04281758 on ClinicalTrials.gov