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临床试验/NCT02760511
NCT02760511已完成不适用

Anthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial

Shaoguan University1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2016年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
122
试验地点
1
主要终点
Plasma 8-iso-prostaglandin concentrations

研究概览

简要总结

Anthocyanins are naturally existing, polyphenolic compounds found in the vacuolar sap of the epidermal tissues of flowers and fruits, with a pink, red, blue, or purple color. Recently, study of anthocyanin pigments has drawn more and more interest since several epidemiological studies have demonstrated their health-promoting properties, such as reducing lipid accumulation and decreasing oxidative stress and inflammation. Nevertheless, there is a clear need for advancing understanding with regard to effective amounts of intake for these phytochemicals. The aim of this study was to investigate the efficacy and pharmacokinetics of anthocyanin in healthy volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • •Blood test, liver function test, renal function test are normal;
  • •Blood lipids, cardiac function are normal;
  • •18.5<BMI<23.9;
  • •Regular dietary, seldomly eating outside;
  • •Stable condition of body weight in recent 3 months

排除标准

  • •> 140 grams of alcohol/week for male and >70 grams of alcohol/week for female, smoking regularly;
  • •Known diagnosis of acute diseases or chronic diseases in recent 1 month;
  • •Be planning to be pregnant in a year, or being pregnant and lactation.

研究组 & 干预措施

Control

Placebo Comparator

Intake of placebo capsules

干预措施: Placebo (Dietary Supplement)

20 mg

Active Comparator

Daily intake of 20 mg anthocyanin

干预措施: Anthocyanin (Dietary Supplement)

40 mg

Active Comparator

Daily intake of 40 mg anthocyanin

干预措施: Anthocyanin (Dietary Supplement)

80 mg

Active Comparator

Daily intake of 80 mg anthocyanin

干预措施: Anthocyanin (Dietary Supplement)

160 mg

Active Comparator

Daily intake of 160 mg anthocyanin

干预措施: Anthocyanin (Dietary Supplement)

320 mg

Active Comparator

Daily intake of 320 mg anthocyanin

干预措施: Anthocyanin (Dietary Supplement)

结局指标

主要结局

Plasma 8-iso-prostaglandin concentrations

时间窗: 2 weeks

Oxidative stress

Plasma total antioxidant capacity

时间窗: 2 weeks

Oxidative stress

Plasma malondialdehyde concentrations

时间窗: 2 weeks

Oxidative stress

次要结局

  • Plasma tumor necrosis factor alpha concentrations(2 weeks)
  • Plasma interleukin-6 concentrations(2 weeks)

研究者

发起方
Shaoguan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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