Efficacy of Polyphenols From Milk and Dark Chocolate

Nestlé

Status: Completed

Conditions: No Disease

Treatments: Dietary Supplement: Dark Chocolate; Dietary Supplement: Control (polyphenol-free) "Chocolate"; Dietary Supplement: Milk Chocolate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00513344

06.38.MET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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6 participants in 3 patient groups

dark chocolate containing polyphenols

Experimental group

Description:

dark chocolate

Treatment:

Dietary Supplement: Dark Chocolate

Milk chocolate containing polyphenols

Experimental group

Description:

Bespoke milk chocolate

Treatment:

Dietary Supplement: Milk Chocolate

Control chocolate with no polyphenols

Active Comparator group

Description:

cocoa-free chocolate

Treatment:

Dietary Supplement: Control (polyphenol-free) "Chocolate"