Cardiovascular Diseases
Conditions
Keywords
theobromine, heart rate, blood lipids
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.
Interventions
DIETARY_SUPPLEMENTTheobromine
Single dose of theobromine
DIETARY_SUPPLEMENTPlacebo
Placebo capsules
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 3 days | Measured during 24h (every 15 minutes during the day and every 30 minutes during the night) for 3 periods |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed