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临床试验/NCT05130359
NCT05130359已完成不适用

Explore Whether Banana Peel Extract Can Improve Sleep

TCI Co., Ltd.1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
TCI Co., Ltd.
入组人数
56
试验地点
1
主要终点
Sleep monitoring

研究概览

简要总结

Banana peel has the potential to improve sleep quality. The purpose of this research is to test the effect of banana peel on improving sleep quality.

详细描述

Insomnia is one of the most frequently complained sleep problems in sleep disorders, and in recent years has been regarded by the medical community as a disease that seriously affects people's lives and quality of life. The problem of perishable and perishable causes a great burden on the environment. However, banana peels actually contain many functional ingredients, such as dietary fiber, minerals, alkaloids, flavonoids, phenols, saponins, tannins and dopamine, etc. Banana peel contains more total phenols and total flavonoids than banana pulp. Studies have pointed out that banana peel extraction can inhibit the growth of fungi and bacteria. In addition, it also has antioxidant, anti-depressant, and diuretic functions. Banana peel can also improve the performance of tryptophan metabolism-related genes

研究设计

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

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.20 to 65-year-old males or non-pregnant females who are willing to sign the subject's consent.
  • 2.Pittsburgh Sleep Quality Index (PSQI) score> 5

排除标准

  • Taking sleeping pills and melatonin
  • People suffering from mental illness
  • Pregnant or breastfeeding women
  • People who are known to be allergic to bananas
  • Have heart-related diseases
  • People with symptoms of sleep cessation

结局指标

主要结局

Sleep monitoring

时间窗: at 4 week after taking test sample

Detect the electrical activity of the heart in the potential difference between two specific points on the body surface to reflect the state of sleep

Serotonin

时间窗: at 4 week after taking test sample

Venous blood was sampled to measure concentrations of Serotonin

Melatonin

时间窗: at 4 week after taking test sample

Collect saliva samples in the morning upon waking to measure melatonin concentration.

Sleeping quality

时间窗: at 4 week after taking test sample

The Pittsburgh Sleep Quality Index (PSQI) will be utilized to assess sleeping quality. The minimum value is 0, the maximum value is 42. The higher the score, the worse the outcome.

Insomnia Severity

时间窗: at 4 week after taking test sample

The Insomnia Severity Index (ISI) will be utilized to assess insomnia severity. The minimum value is 0, the maximum value is 28. The higher the score, the worse the outcome.

次要结局

未报告次要终点

研究者

发起方
TCI Co., Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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