The Effect of Theobromine on Blood Lipid Parameters in Healthy Subjects
NCT ID: NCT01481389
Last Updated: 2012-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2010-12-31
Brief Summary
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Hypothesis: theobromine has a positive effect on blood lipid parameters.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Theobromine drink
Theobromine
200 ml drink with added theobromine (no cocoa added)
Cocoa drink
Cocoa
200 ml drink with cocoa (no theobromine added)
Placebo drink
Placebo
200 ml drink (no added theobromine or cocoa)
Cocoa and theobromine drink
Cocoa and theobromine
200 ml drink with added cocoa and theobromine
Interventions
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Theobromine
200 ml drink with added theobromine (no cocoa added)
Cocoa
200 ml drink with cocoa (no theobromine added)
Cocoa and theobromine
200 ml drink with added cocoa and theobromine
Placebo
200 ml drink (no added theobromine or cocoa)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
70 Years
ALL
Yes
Sponsors
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Unilever R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Wieneke Koppenol, MSc
Role: STUDY_DIRECTOR
Unilever R&D
Nicole Neufingerl, MSc
Role: STUDY_DIRECTOR
Unilever R&D
Locations
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Eurofins Optimed
Gières, , France
Countries
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References
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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.
Other Identifiers
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10022V
Identifier Type: -
Identifier Source: org_study_id