Clinical trial NCT01544829: The Acute Effect of 2 Different Serving Regimens of Theobromine on Physiological Effects
Official title: The Acute Effect of 2 Different Serving Regimens of Theobromine on Theobromine Concentration in the Blood & Physiological Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: theobromine
heart rate
blood lipids
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2012-03-06
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Heart rate
timeFrame: 3 days
Secondary outcomes:
measure: Blood pressure
timeFrame: Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods
measure: Hematocrit
timeFrame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
measure: Serum blood lipids
timeFrame: Measured on day 1 and 2 (at time points -5min and 24h) for 3 periods
measure: Serum glucose and insulin concentrations
timeFrame: Measured on day 1 and 2 (at time points -5min, 3h, 5h, 10h and 24h) for 3 periods
Other outcomes:
Locations:
city: Gieres
country: France
facility: Eurofins Optimed
Study officials:
affiliation: Unilever R&D
name: Wieneke Koppenol, MSc
role: STUDY_DIRECTOR
References: