Anthocyanin Dose-escalation Study in Healthy Young Adults: A CONSORT-compliant, Randomized, Controlled Trial
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
Intake of placebo capsules
干预措施: Placebo (Dietary Supplement)
20 mg
Daily intake of 20 mg anthocyanin
干预措施: Anthocyanin (Dietary Supplement)
40 mg
Daily intake of 40 mg anthocyanin
干预措施: Anthocyanin (Dietary Supplement)
80 mg
Daily intake of 80 mg anthocyanin
干预措施: Anthocyanin (Dietary Supplement)
160 mg
Daily intake of 160 mg anthocyanin
干预措施: Anthocyanin (Dietary Supplement)
320 mg
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)
