Comparison of Plasma Caffeine Concentration After Oral Consumption of Caffeinated Beverages With Varied Bioactive Compounds in Healthy Volunteers
NCT ID: NCT04281758
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2020-07-20
2020-10-13
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Caffeine beverage (control)
Flavored still beverage with caffeine 100 mg
Beverage
16 oz (473.2 ml)
Caffeine beverage plus bioactive 1
Flavored still beverage with caffeine 100 mg + quercetin 250 mg
Beverage
16 oz (473.2 ml)
Caffeine beverage plus bioactive 2
Flavored still beverage with caffeine 100 mg + curcumin 80 mg
Beverage
16 oz (473.2 ml)
Caffeine beverage plus bioactive 3
Flavored still beverage with caffeine 100 mg + methylliberine 75 mg
Beverage
16 oz (473.2 ml)
Interventions
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Beverage
16 oz (473.2 ml)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
55 Years
MALE
Yes
Sponsors
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PepsiCo Global R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Trisha R Shamp, PhD
Role: PRINCIPAL_INVESTIGATOR
Prism Clinical Research
Locations
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Prism Clinical Research
Saint Paul, Minnesota, United States
Countries
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Other Identifiers
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PEP-1913
Identifier Type: -
Identifier Source: org_study_id