No Disease
Conditions
Keywords
Endothelial function, Arterial stiffness, Dark chocolate, Milk chocolate, Polyphenols
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.
Interventions
DIETARY_SUPPLEMENTDark Chocolate
1 portion
DIETARY_SUPPLEMENTMilk Chocolate
1 portion
DIETARY_SUPPLEMENTControl (polyphenol-free) Chocolate
one portion
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake | Baseline and 2 hours | Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake | baseline and 2 hours | Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff. An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia. |
Countries
Switzerland
Participant flow
Recruitment details
5 healthy subjects, 2 females and 3 males, were recruited within the staff of the Nestlé Research Center in June-July 2008.
Pre-assignment details
From 3 days before the first test session no foods containing epicatechin or catechin or procyanidins should be ingested. The subjects received a single dose of the 3 products in a randomised order with a minimum of 3 days washout in between (crossover design). The duration of the study was a minimum of 15 days.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 34 years STANDARD_DEVIATION 7 |
| Age, Customized <= 28 years | 0 participants |
| Age, Customized >= 42 years | 0 participants |
| Age, Customized between 28 and 42 years | 5 participants |
| Region of Enrollment Switzerland | 5 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake
Value of RHI at 2 hours minus value at baseline. RHI reflects the endothelial function of a vessel at the distal phalanx of a finger, i.e. the capacity of the vessel to dilate after an ischemia. RHI is the increase of blood flow following the occlusion of the brachial artery during 5 minutes by the inflation of an armcuff. RHI was measured by peripheral arterial tonometry using a fingerprobe connected to an EndoPat analyser.
Time frame: Baseline and 2 hours
Population: Taking into account the fact that there is no background data and that we need to have accurate evaluation of central tendency and dispersion, a minimum of five complete subjects are needed.~Data from all randomized subjects were considered in the intention to treat model (for the primary outcome).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Chocolate With no Polyphenols | Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake | 2.12 percentage of the pulse wave amplitude | Standard Error 0.52 |
| Milk Chocolate Containing Polyphenols | Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake | 2.30 percentage of the pulse wave amplitude | Standard Error 0.71 |
| Dark Chocolate Containing Polyphenols | Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake | 2.26 percentage of the pulse wave amplitude | Standard Error 0.65 |
Secondary
Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake
Value of arterial stiffness at 2 hours minus value at baseline. Arterial stiffness is also automatically calculated by peripheral arterial tonometry which consists in measuring the peripheral vessel endothelial response to an ischemia provoked by a 5-min occlusion of the humeral artery using an armcuff. An increase in arterial stiffness means an increase in the resistance of the vessel wall which reflects an impaired endothelial response to ischemia.
Time frame: baseline and 2 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Chocolate With no Polyphenols | Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake | -13.23 percentage of baseline | Standard Deviation 11.16 |
| Milk Chocolate Containing Polyphenols | Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake | 1.23 percentage of baseline | Standard Deviation 12.87 |
| Dark Chocolate Containing Polyphenols | Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake | -9.49 percentage of baseline | Standard Deviation 15.03 |