Cardiovascular Diseases
Conditions
Keywords
Blood lipids, risk factor for cardiovascular diseases
Brief summary
The purpose of this study is to determine the effect of theobromine on blood lipid parameters in healthy subjects. Secondary objectives are to determine the effect of cocoa and an interaction effect of cocoa and theobromine on blood lipid parameters. Hypothesis: theobromine has a positive effect on blood lipid parameters.
Interventions
DIETARY_SUPPLEMENTTheobromine
200 ml drink with added theobromine (no cocoa added)
DIETARY_SUPPLEMENTCocoa
200 ml drink with cocoa (no theobromine added)
DIETARY_SUPPLEMENTCocoa and theobromine
200 ml drink with added cocoa and theobromine
DIETARY_SUPPLEMENTPlacebo
200 ml drink (no added theobromine or cocoa)
Sponsors
Unilever R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
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) * Willing and able to participate in the study protocol * Written informed consent * Age 40-70 years * 10-year risk of developing CHD \<10%, based on data from the Framingham Heart Study * BMI \> 18 and \< 30 kg/m2 * Blood pressure, heart rate, haematological and clinical chemical parameters within the normal reference range as judged by research physician * Willing to comply with the dietary restrictions of the study. * Accessible veins on arm(s) as determined by examination at screening
Exclusion criteria
* Previous cardiovascular event(s) (stroke, TIA, angina, myocardial infarction, heart failure) * Diabetes mellitus * Reported alcohol consumption \> 14 units/week (female) or \> 21 units/week (male) * Currently on a medically prescribed diet, or slimming diet * Reported weight loss or gain of 10% body weight or more during a period of 6 months before pre-study examination * Reported intense sporting activities \> 10 h/w * Use of 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 study. * 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 * Reported intolerance to test products or other food products provided during the study * Blood donation 1 month (males) or 2 months (females) prior to screening and during the study * Reported participation in another nutritional or biomedical trial 3 months before screening or during the study. * Extreme coffee consumption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood lipids | after 4 weeks intervention |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure | After 4 weeks intervention |
| Heart rate | After 4 weeks intervention |
Countries
France
Outcome results
None listed