Efficacy of Polyphenols From Milk and Dark Chocolate

NCT ID: NCT00513344

Last Updated: 2013-08-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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No Disease

Keywords

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Endothelial function Arterial stiffness Dark chocolate Milk chocolate Polyphenols

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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dark chocolate containing polyphenols

dark chocolate

Group Type EXPERIMENTAL

Dark Chocolate

Intervention Type DIETARY_SUPPLEMENT

1 portion

Milk chocolate containing polyphenols

Bespoke milk chocolate

Group Type EXPERIMENTAL

Milk Chocolate

Intervention Type DIETARY_SUPPLEMENT

1 portion

Control chocolate with no polyphenols

cocoa-free chocolate

Group Type ACTIVE_COMPARATOR

Control (polyphenol-free) "Chocolate"

Intervention Type DIETARY_SUPPLEMENT

one portion

Interventions

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Dark Chocolate

1 portion

Intervention Type DIETARY_SUPPLEMENT

Milk Chocolate

1 portion

Intervention Type DIETARY_SUPPLEMENT

Control (polyphenol-free) "Chocolate"

one portion

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen A Cooper, PhD

Role: PRINCIPAL_INVESTIGATOR

Société des Produits Nestlé (SPN)

Gary Williamson, PhD

Role: STUDY_DIRECTOR

Société des Produits Nestlé (SPN)

Locations

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Nestle Research Center

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 17312446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16877960 (View on PubMed)

Other Identifiers

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06.38.MET

Identifier Type: -

Identifier Source: org_study_id