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

NCT04281758 | Completed Phase 1

• 1 other identifier: PEP-1913
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

caffeine; botanicals; beverage; mood

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Caffeine concentration

  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)

  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)

  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)

  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

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

Study Arms (4)

Caffeine beverage (control)

ACTIVE COMPARATOR

Flavored still beverage with caffeine 100 mg

Other: Beverage

Caffeine beverage plus bioactive 1

EXPERIMENTAL

Flavored still beverage with caffeine 100 mg + quercetin 250 mg

Other: Beverage

Caffeine beverage plus bioactive 2

EXPERIMENTAL

Flavored still beverage with caffeine 100 mg + curcumin 80 mg

Other: Beverage

Caffeine beverage plus bioactive 3

EXPERIMENTAL

Flavored still beverage with caffeine 100 mg + methylliberine 75 mg

Other: Beverage

Interventions

Beverage OTHER

16 oz (473.2 ml)

Caffeine beverage (control); Caffeine beverage plus bioactive 1; Caffeine beverage plus bioactive 2; Caffeine beverage plus bioactive 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Prism Clinical Research

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

Beverages

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Trisha R Shamp, PhD

  Prism Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Beverage types are as similar as possible in terms of taste, aroma and color.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 24, 2020
• Study Start: July 20, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 13, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)