Status:
COMPLETED
The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
Lead Sponsor:
Unilever R&D
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
40-70 years
Phase:
NA
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT01481389
Start Date
December 1 2010
Last Update
September 18 2012
Active Locations (1)
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1
Eurofins Optimed
Gières, France, 38610