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临床试验/NCT00492713
NCT00492713已完成不适用

Comparison of the Bioavailability 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 18 人开始时间: 2007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
18
试验地点
2
主要终点
AUC plasma polyphenols

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 of epicatechin from milk chocolate was reduced compared to dark. The primary outcome measure is to compare plasma polyphenol levels after consumption of 3 chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax for use in future studies.

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 lipophillic 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. Previous bioavailability trials with dark chocolate have shown a 12 fold increase in plasma epicatechin 2 hours after consumption of 80g of chocolate containing 557 mg total polyphenols (137 mg epicatechin) (Rein et al 2000) with a concurrent increase in plasma total antioxidant capacity and a decrease in TBARS. Another study showed an increase in epicatechin 2 hours after administering 25g of chocolate chips containing 220 mg flavanols and procyanidins, with a concurrent increase in prostacyclin/leukotriene ratio and reduction in platelet-related hemostasis (Holt et al 2002).

This study is designed as a blinded, three arm crossover trial. The primary outcome measure is to compare plasma polyphenol levels after consumption of 3 chocolates (2 milk, 1 dark) while the secondary outcome measures are to characterise the time course of polyphenols in the blood and to investigate individual variation in Tmax and Cmax for use in future studies. All volunteers will try all chocolate types with a similar taste & appearance (though milk and dark are likely to still be distinguishable for the volunteer, not the investigator). Subjects will undergo medical screening, anthropometry, physical activity and dietary assessments before randomisation for the order of consumption. Bloods are to be taken as a time course for the next 24 hours, as is urine.

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
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 19 - 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

AUC plasma polyphenols

时间窗: 24 hours

次要结局

  • Tmax and Cmax of plasma polyphenols(24 hours)
  • Plasma and urinary metabolite identification and quantification(24 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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