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

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 Overview

• Status: Completed
• Conditions: Plasma Caffeine Concentration
• Intervention / Treatment: Other: Beverage

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Prism Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Caffeine beverage (control); Flavored still beverage with caffeine 100 mg	Other: Beverage; 16 oz (473.2 ml)
Experimental: Caffeine beverage plus bioactive 1; Flavored still beverage with caffeine 100 mg + quercetin 250 mg	Other: Beverage; 16 oz (473.2 ml)
Experimental: Caffeine beverage plus bioactive 2; Flavored still beverage with caffeine 100 mg + curcumin 80 mg	Other: Beverage; 16 oz (473.2 ml)
Experimental: Caffeine beverage plus bioactive 3; Flavored still beverage with caffeine 100 mg + methylliberine 75 mg	Other: Beverage; 16 oz (473.2 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental area-under-the-concentration-curve (iAUC)	Plasma caffeine level	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caffeine concentration	Plasma caffeine level	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	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	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	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.	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.	At each of 4 testing days pre-dose, and 60 min, 120 min, and 210 min post-dose

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Trisha R Shamp, PhD, Prism Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 13, 2020

Study Registration Dates

• First Submitted: February 19, 2020
• First Submitted That Met QC Criteria: February 20, 2020
• First Posted (Actual): February 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: caffeine; mood; beverage; botanicals
• Other Study ID Numbers: PEP-1913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No