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临床试验/NCT01790009
NCT01790009已完成1 期

Influence of Age on the Absorption and Metabolism of Cocoa Flavanols

University of Reading1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
40
试验地点
1
主要终点
Plasma and urine flavanol metabolites

研究概览

简要总结

Accumulating evidence suggests that regular consumption of foods and beverages rich in flavanols, such as cocoa, tea, apples and wine, may have cardiovascular benefits. Several well-controlled randomised human intervention studies have shown that cocoa flavanols have beneficial effects on blood pressure, endothelial function and other biomarkers of cardiovascular health. These vascular improvements have been correlated in time with changes in plasma flavanol metabolites. The health benefits of flavanol consumption are therefore likely dependent on changes in their absorption, distribution, metabolism and excretion (ADME). Recent studies have provided detailed information regarding the absorption and metabolism of cocoa flavanols. However, there is a lack of information on whether there are changes in flavanol absorption and metabolism with increasing age.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • signed consent form
  • Caucasian
  • Good general health
  • No allergy to milk products or sensitivity to alkaloids/caffeine,
  • No gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, irritable bowel syndrome, or other chronic gastrointestinal complaints)
  • Not diabetic or suffering from hypertension (140/90 mm Hg),
  • No anaemia or gall bladder problems.

排除标准

  • those on a weight reducing dietary regimen
  • Taking any dietary supplements
  • Consuming more than 15 units (120g) of alcohol per week
  • Taking anti-inflammatory medication
  • Those with sensitivities to chocolate, reduced calorie sweeteners, dairy, nuts or gluten,
  • Vegetarians or vegans.

研究组 & 干预措施

Acetaminophen

Active Comparator

2 tabletsx500 mg

干预措施: Acetaminophen (Drug)

Flavanol Rich drink

Active Comparator

Flavanol-rich drink containing 800 mg/75 Kg of Body Weight (BW)

干预措施: Flavanol rich drink (Dietary Supplement)

Flavanol rich drink

Active Comparator

Flavanol Intervention drink 400 mg/75 Kg BW

干预措施: Flavanol rich drink (Dietary Supplement)

结局指标

主要结局

Plasma and urine flavanol metabolites

时间窗: 24 hours

次要结局

  • Paracetamol and methylxanthine plasma and urine levels(24 h)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy Paul Edward Spencer

Professor

University of Reading

研究点 (1)

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