跳至主要内容
临床试验/NCT05911516
NCT05911516招募中不适用

Effects of Pennisetum Purpureum Health Food Supplementation on Muscle Mass and Muscle Strength

Taipei Medical University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Body height

研究概览

简要总结

The purpose of this study was to investigate the effects of Pennisetum purpureum health food supplementation on muscle mass and muscle strength.

详细描述

All participants performed anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey before supplementation. Participants were assigned to either the experimental (n=20) or placebo (n=20) group according to their body composition, upper arm circumference, and lower thigh circumference. The definition of insufficient muscle mass was based on the Asian working group for sarcopenia (AWGS) that skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women is a necessary condition, and one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than12 seconds. The anthropometric measurements (body height, body weight, BMI, blood pressure, body composition, upper arm circumference, and lower thigh circumference), blood collection (hormones, liver function, and kidney function), exercise test (grip strength and 10-m walking test), as well as questionnaire survey, were collected after 8 weeks and 12 weeks of supplementation.

研究设计

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

盲法说明

A double-blind, matched-pair study design

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult between 18-75 years old
  • skeletal muscle mass in extremities by dual-energy X-ray absorptiometry less than 7.0 kg/m2 in men and less than 5.4 kg/m2 in women
  • one of the following criteria were met: (1) handgrip strength less than 28 kg in men and less than 18 kg in women and (2) 5-time chair stand test over than 12 seconds

排除标准

  • The volunteers have history of cardiovascular, liver, kidney, and diabetes mellitus
  • acute sport injury
  • participated in any clinical trials or experimental research in the last 3 months before our experiment
  • taking supplement during the experimental period
  • did not maintain their regular eating habit or drink alcohol

结局指标

主要结局

Body height

时间窗: 12 weeks of supplementation

Cortisol level

时间窗: 12 weeks of supplementation

Growth Hormone level

时间窗: 12 weeks of supplementation

Insulin-like Growth Factor-1

时间窗: 12 weeks of supplementation

Diastolic blood pressure

时间窗: 12 weeks of supplementation

Body weight

时间窗: 12 weeks of supplementation

ASM (Appendicular Skeletal Muscle Mass)

时间窗: 8 weeks of supplementation

Upper Arm Circumference

时间窗: 12 weeks of supplementation

Testosterone level

时间窗: 12 weeks of supplementation

Thigh Circumference

时间窗: 12 weeks of supplementation

follistain level

时间窗: 12 weeks of supplementation

myostain level

时间窗: 12 weeks of supplementation

BMI (body mass index)

时间窗: 12 weeks of supplementation

Systolic blood pressure

时间窗: 12 weeks of supplementation

Grip Strength

时间窗: 12 weeks of supplementation

10-Meter Walk Test

时间窗: 12 weeks of supplementation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Pennisetum Purpureum in Sarcopenia Patients | 临床试验