Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Nutritional Status
研究概览
简要总结
Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.
To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.
详细描述
Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Colorectal Carcinoma
- •Have undergone standard therapy
- •Satisfactory haematological or biochemical functions
- •Karnofsky performance status of ≥ 60%
- •Willing not to take probiotic supplement during study period
排除标准
- •Uncontrolled hypertension
- •Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
- •Physical and mental disability that renders them unable to verbally communicate
- •History of recent cancers
- •Pregnant, lactating, or not using adequate contraception
- •Patient on other investigational drug
结局指标
主要结局
Nutritional Status
时间窗: eight weeks
次要结局
- Cytotoxicity(two days)