Clinical trial NCT01481389: The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Official title: The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Blood lipids
risk factor for cardiovascular diseases
Lead sponsor: Unilever R&D
Sponsor class: INDUSTRY
First posted: 2011-11-29
Enrollment: 152
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood lipids
timeFrame: after 4 weeks intervention
Secondary outcomes:
measure: Blood pressure
timeFrame: After 4 weeks intervention
measure: Heart rate
timeFrame: After 4 weeks intervention
Other outcomes:
Locations:
city: Gieres
country: France
facility: Eurofins Optimed
Study officials:
affiliation: Unilever R&D
name: Wieneke Koppenol, MSc
role: STUDY_DIRECTOR
affiliation: Unilever R&D
name: Nicole Neufingerl, MSc
role: STUDY_DIRECTOR
References:
citation: Neufingerl N, Zebregs YE, Schuring EA, Trautwein EA. Effect of cocoa and theobromine consumption on serum HDL-cholesterol concentrations: a randomized controlled trial. Am J Clin Nutr. 2013 Jun;97(6):1201-9. doi: 10.3945/ajcn.112.047373. Epub 2013 Apr 17.