Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2008-06-30
2012-04-30
Brief Summary
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Detailed Description
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This study is designed as a blinded, three arm crossover trial. The primary outcome measure is to compare endothelial function after consumption of 3 chocolates (1 milk, 1 dark, 1 polyphenol-free control) with a secondary outcome of arterial stiffness. All volunteers will take all chocolate types in a crossover design. Subjects will undergo medical screening, anthropometry, physical activity and dietary assessments before randomization for the order of consumption.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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dark chocolate containing polyphenols
dark chocolate
Dark Chocolate
1 portion
Milk chocolate containing polyphenols
Bespoke milk chocolate
Milk Chocolate
1 portion
Control chocolate with no polyphenols
cocoa-free chocolate
Control (polyphenol-free) "Chocolate"
one portion
Interventions
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Dark Chocolate
1 portion
Milk Chocolate
1 portion
Control (polyphenol-free) "Chocolate"
one portion
Eligibility Criteria
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Inclusion Criteria
* Healthy as determined by the medical questionnaire
* Normal weight: BMI 19 - 25
* Having given informed consent
Exclusion Criteria
* Have had a major gastrointestinal surgery.
* Have a regular consumption of medication.
* Have an exceptionally high intake of chocolate or similarly high polyphenol foods.
* Have a high and regular intake of vitamin supplements
* Have an alcohol intake: \> 2 units a day
* Patient who cannot be expected to comply with treatment.
* Smoker
* Having a nut allergy
* Unwilling to consume chocolate
* Currently participating or having participated in another clinical trial during the last 3 weeks.
* Having given blood in the past three weeks
* More than 3 x 45 min of exercise per week
25 Years
45 Years
ALL
Yes
Sponsors
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Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Karen A Cooper, PhD
Role: PRINCIPAL_INVESTIGATOR
Société des Produits Nestlé (SPN)
Gary Williamson, PhD
Role: STUDY_DIRECTOR
Société des Produits Nestlé (SPN)
Locations
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Nestle Research Center
Lausanne, Canton of Vaud, Switzerland
Countries
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References
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Heiss C, Finis D, Kleinbongard P, Hoffmann A, Rassaf T, Kelm M, Sies H. Sustained increase in flow-mediated dilation after daily intake of high-flavanol cocoa drink over 1 week. J Cardiovasc Pharmacol. 2007 Feb;49(2):74-80. doi: 10.1097/FJC.0b013e31802d0001.
Fisher ND, Hollenberg NK. Aging and vascular responses to flavanol-rich cocoa. J Hypertens. 2006 Aug;24(8):1575-80. doi: 10.1097/01.hjh.0000239293.40507.2a.
Other Identifiers
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06.38.MET
Identifier Type: -
Identifier Source: org_study_id