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临床试验/NCT03201926
NCT03201926Unknown不适用

Development and Clinical Application of Invalid Foods Using Mealworms

Yonsei University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2017年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
168
试验地点
1
主要终点
Improvement of Body mass index

研究概览

简要总结

Malnutrition in cancer patients continues after surgery and worsens the patient's overall health and quality of life. Previous studies reported edible insects in patients' diets increased postoperative muscle mass and weight gain. Therefore, by using nutritionally excellent mealworms for a long time, it is proved that nutritional status and survival rate are improved, leading to development of various products of edible insects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients scheduled for surgery with pancreaticobiliary disease and liver cancer (metastatic liver cancer)
  • •Karnofsky performance status ≥ 70
  • •Patients who can communicate without difficulty in obtaining a consent form for the test

排除标准

  • •Patients with any of the following criteria are excluded.
  • •Patients who underwent palliative surgery
  • •Patients with uncontrolled pre-operative disease
  • •Previous history of surgery affecting nutritional status
  • •Pregnant and lactating women
  • •Patients with allergy to mealworms

研究组 & 干预措施

mealworms

Experimental

mealworms

干预措施: mealworms (Dietary Supplement)

grain powder

Placebo Comparator

grain powder

干预措施: grain powder (Dietary Supplement)

结局指标

主要结局

Improvement of Body mass index

时间窗: Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms)

Improvement of Nutrition index ( Body cell mass, Soft lean mass, Fat free mass, Fat mass)

次要结局

  • Improvement of Immune Function Index(Changes from baseline nutition index at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms))
  • Improvement of Body weight change(Changes from baseline Body weight at Preoperative 1 day, Postoperative 14 days (one week after take mealworms), Postoperative 2 months( two months after take mealworms))

研究者

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

Joon Seong Park

Principal Investigator

Yonsei University

研究点 (1)

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