Clinical trial NCT00513344: Efficacy of Polyphenols From Milk and Dark Chocolate
Official title: Efficacy of Polyphenols From Milk and Dark Chocolate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: No Disease
Keywords: Endothelial function
Arterial stiffness
Dark chocolate
Milk chocolate
Polyphenols
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2007-08-08
Enrollment: 6
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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 criteria: Inclusion Criteria:

* 25- 45 years, male and female
* Healthy as determined by the medical questionnaire
* Normal weight: BMI 19 - 25
* Having given informed consent

Exclusion Criteria:

* Intestinal or metabolic diseases/disorders such as diabetic, renal, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
* 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

Primary outcomes:
measure: Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake
timeFrame: Baseline and 2 hours
Secondary outcomes:
measure: Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake
timeFrame: baseline and 2 hours
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nestle Research Center
state: Vaud
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Karen A Cooper, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Société des Produits Nestlé (SPN)
name: Gary Williamson, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.