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临床试验/NCT00513344
NCT00513344已完成不适用

Efficacy of Polyphenols From Milk and Dark Chocolate

Société des Produits Nestlé (SPN)2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2008年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
6
试验地点
2
主要终点
Change in Reactive Hyperemia Index (RHI) From Baseline (20 Min Before Product Intake) to 2 Hours Following Product Intake

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.
  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Change in Arterial Stiffness From Baseline (20 Min Before Product Intake) to Two Hours Following Product Intake(baseline and 2 hours)

研究者

发起方
Société des Produits Nestlé (SPN)
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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Efficacy of Polyphenols From Milk and Dark Chocolate | 临床试验