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| Sponsor: | Nestle Research Center |
|---|---|
| Information provided by: | Nestle Research Center |
| ClinicalTrials.gov Identifier: | NCT00513344 |
Purpose
Dark chocolate is one of the richest sources of polyphenols though it has been hypothesised that the bioavailability and therefore probably the bioefficacy of epicatechin from milk chocolate was reduced compared to dark. This study is designed to compare milk and dark chocolate as a source of polyphenols with a control "chocolate" for improving a risk biomarker for vascular disease.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: Dark Chocolate Dietary Supplement: Milk Chocolate Dietary Supplement: Control (polyphenol-free) "Chocolate" |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Single Blind, Active Control, Crossover Assignment, Efficacy Study |
| Official Title: | Efficacy of Polyphenols From Milk and Dark Chocolate |
| Estimated Enrollment: | 6 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2008 |
Dark chocolate is one of the richest sources of polyphenols, for example, a standard 40g portion of dark chocolate contains 400-800 mg of polyphenols, compared to red wine (170 mg /100ml) or an apple (200 mg/piece). Cocoa polyphenols, most notably the catechins, can exist in both lipid and water-based environments (amphipathic), meaning they can spare both lipophilic and hydrophilic vitamins. There have been a number of human trials conducted using chocolate or cocoa and measuring various endpoints. Most have been conducted with dark chocolate. An article in Nature found that the bioavailability of epicatechin from milk chocolate was substantially reduced compared to dark, and even dark taken with a glass of milk (Serafini et al 2003). The hypothesis was that the milk proteins bind to polyphenols, making them unavailable. Subsequent studies have not been able to reproduce this, but none have been conducted using solid chocolate as the first study, all have been done using a drink matrix, which may completely alter the binding interactions of the polyphenols and protein. To this end, this study is designed to compare solid chocolates as a source of polyphenols for improving a risk biomarker for vascular disease.
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.
Eligibility| Ages Eligible for Study: | 25 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen A Cooper, PhD | 00 41 21 785 9431 | karen.cooper@rdls.nestle.com |
| Contact: Maurice Beaumont, MD | 00 41 21 785 8054 | maurice.beaumont@rdls.nestle.com |
| Switzerland, Vaud | |
| Nestle Research Center | Recruiting |
| Lausanne, Vaud, Switzerland, 1000 | |
| Principal Investigator: | Karen A Cooper, PhD | Nestle Research Center |
| Study Director: | Gary Williamson, PhD | Nestle Research Center |
More Information
| Responsible Party: | Nestle Research Center ( Dr Karen Cooper ) |
| Study ID Numbers: | 06.38.MET |
| Study First Received: | August 6, 2007 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00513344 History of Changes |
| Health Authority: | Switzerland: Ethikkommission |
|
Endothelial function Arterial stiffness Dark chocolate Milk chocolate Polyphenols |