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临床试验/NCT05953116
NCT05953116
已完成
不适用

Managing the Nutritional Needs of Older Filipino with Due Attention to Protein Nutrition and Functional Health (ManoPo) Study

Food and Nutrition Research Institute, Philippines1 个研究点 分布在 1 个国家目标入组 68 人2023年9月4日
适应症Sarcopenia

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Sarcopenia
发起方
Food and Nutrition Research Institute, Philippines
入组人数
68
试验地点
1
主要终点
Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)
状态
已完成
最后更新
去年

概览

简要总结

The study aims to determine the effect of protein nutrition and exercise on the body composition and functional capacity of Filipino older adults.

详细描述

The objective of the study is to determine the effects of nutrition supplementation and exercise intervention on the main indicators of sarcopenia in older adults such as body composition (fat mass and lean mass), muscle strength (leg and handgrip), and physical performance.

注册库
clinicaltrials.gov
开始日期
2023年9月4日
结束日期
2024年9月30日
最后更新
去年
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
Food and Nutrition Research Institute, Philippines
责任方
Principal Investigator
主要研究者

Robby Carlo A. Tan

Senior Science Research Specialist

Food and Nutrition Research Institute, Philippines

入排标准

入选标准

  • Pre-sarcopenia/pre-frail
  • Aged 60 years old and above, male or female
  • Free-living in the community, ambulatory
  • Able to respond to food recall/interview as self-declared
  • Normal cardiac function as measured by resting ECG

排除标准

  • Bed ridden, unable to perform exercise independently
  • Presence of serious medical condition (i.e. cancer, existing fracture)
  • Presence of unmanaged hypertension and/or type 2 diabetes or upon assessment of physician
  • Renal Problem
  • Under controlled or medically-supervised diet not flexible to include the intervention agent
  • Allergic to any ingredients in the nutrition supplementation

结局指标

主要结局

Change in muscle strength, as measured by grip strength and leg strength (Jamar, MicroFET)

时间窗: Baseline, Midline (6 weeks), Endline (12 weeks)

Handgrip strength is measured using a hydraulic hand dynamometer through maximum exertion of grip force (in kilograms). Leg strength is measured using a hand-held dynamometer. Participant will use strongest leg force to push against the resistance brought upon by the researcher while holding the measuring device.

Change in physical performance, as measured by timed up-and-go test

时间窗: Baseline, Midline (6 weeks), Endline (12 weeks)

Faster time duration to complete the test indicate lesser risk for falls

Change in physical performance, as measured by short physical performance battery

时间窗: Baseline, Midline (6 weeks), Endline (12 weeks)

Score ranges from 0 to 12 with a higher score indicating better functionality

Change in physical performance, as measured by 10-meter walk test

时间窗: Baseline, Midline (6 weeks), Endline (12 weeks)

Faster walking speed (in meters per second) indicate better functionality

Change in muscle mass, as measured by dual-energy x-ray absorptiometry (DXA)

时间窗: Baseline, Midline (6 weeks), Endline (12 weeks)

Measurement of appendicular skeletal muscle mass index (ASMI) by dividing total muscle mass (kg) of appendages with height in meters squared

研究点 (1)

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