The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects

NCT01544829 — Not applicable, Completed, 12 participants, Unilever R&D

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The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects

Registry	NCT01544829
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: quadruple, basic science
Enrollment	12 (Actual)
Sponsor	Unilever R&D (Industry)
Conditions	Cardiovascular Diseases
Interventions	Theobromine, Placebo (Dietary supplement)
Dates	start 2012-02-01, primary completion 2012-04-01, completion 2012-06-01, first posted 2012-03-06, last updated 2012-12-03
Locations	1 site in France

-Summary

The main aim of this study is to determine whether there is a difference in the physiological effects of theobromine when provided via a single serving compared to multiple servings adding up to the same amount of theobromine provided on a day.

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.

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+Arms and interventions

Arm	Type	Interventions
Active Comparator: Single serving of theobromine	Active comparator	Dietary Supplement: Theobromine
Multiple servings of theobromine	Active comparator	Dietary Supplement: Theobromine
Placebo capsules	Placebo comparator	Dietary Supplement: Placebo

Theobromine (Dietary supplement): Single dose of theobromine
Theobromine (Dietary supplement): Multiple doses of theobromine
Placebo (Dietary supplement): Placebo capsules

+Outcome measures

Primary outcomes

Heart rate [3 days]: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods

Secondary outcomes

Blood pressure [Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods]
Hematocrit [Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods]
Serum blood lipids [Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods]
Serum glucose and insulin concentrations [Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods]

+Eligibility

Sex: All, ages: 40 Years to 70 Years, accepts healthy volunteers

Inclusion Criteria:

* Apparently healthy men and post-menopausal women: no medical conditions which might affect study measurements (judged by study physician)
* 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:

* Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure)
* 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

+Locations (1)

Facility	City	Country	Status
Eurofins Optimed	Gières	France

+Investigators

Wieneke Koppenol, MSc, Study director, Unilever R&D