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Completed

NCT Number: NCT00513344

Efficacy of Polyphenols From Milk and Dark Chocolate

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.

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Key information

Conditions

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nestle Research Center

Lausanne, Canton of Vaud, 1000, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dark chocolate

Dietary Supplement

1 portion

Milk Chocolate

Dietary Supplement

1 portion

Control (polyphenol-free) "Chocolate"

Dietary Supplement

one portion

Primary outcomes

  1. Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake

    Time frame: 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 outcomes

  1. Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2012
First posted
Aug 8, 2007
Registry last updated
Aug 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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