Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 2
- 主要终点
- LOOH and MDA-DNA adducts
研究概览
简要总结
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.
排除标准
- •concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins
研究组 & 干预措施
29.5 mL noni dose
Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.
干预措施: Noni juice (Dietary Supplement)
59 mL noni juice
Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days.
干预措施: Noni juice (Dietary Supplement)
Placebo
Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
LOOH and MDA-DNA adducts
时间窗: 1 month
LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.
次要结局
- adverse events(1 month)