The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects
NCT ID: NCT01544829
Last Updated: 2012-12-03
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
NA
12 participants
INTERVENTIONAL
2012-02-29
2012-06-30
Brief Summary
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This study also aims to study the pharmacokinetics of theobromine after administration once per day versus administration 4 times per day.
Hypothesis: the effects on heart rate are less pronounced when a high dose of theobromine is given in 4 smaller doses.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Active Comparator: Single serving of theobromine
Theobromine
Single dose of theobromine
Multiple servings of theobromine
Theobromine
Multiple doses of theobromine
Placebo capsules
Placebo
Placebo capsules
Interventions
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Theobromine
Single dose of theobromine
Theobromine
Multiple doses of theobromine
Placebo
Placebo capsules
Eligibility Criteria
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Inclusion Criteria
* Age 40-70 years
* BMI ≥ 18 and ≤ 30 kg/m2
* Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged non clinically significant by research physician
* Written informed consent
Exclusion Criteria
* Diabetes mellitus
* Reported weight loss or gain of 10% body weight or more during a period of 6 months prior to screening
* Reported intense sporting activities \> 10 h/week
* Use of over-the -counter prescribed medication which may interfere with study measurements, as judged by the physician
* Use of antibiotics in the three months before screening or during the run-in period.
* Currently smoking or being a non-smoker for less than 6 months and reported use of any nicotine containing products in the 6 months preceding the study and during the study itself
* High caffeine consumption: reported consumption of more than 8 cups/cans of caffeine-containing drinks per day, i.e. coffee, black or green tea and cola (also cola light, diet \& zero) OR consumption of more than 1 energy drink per day
40 Years
70 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Wieneke Koppenol, MSc
Role: STUDY_DIRECTOR
Unilever R&D
Locations
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Eurofins Optimed
Gières, , France
Countries
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Other Identifiers
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FDS-SCC-0465
Identifier Type: -
Identifier Source: org_study_id