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Protein Supplementation Intervention for Improving Muscle Mass and Physical Performance in Older People With Sarcopenia

NCT04516421 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-02-14

No results posted yet for this study

Summary

Background: Declines in muscle mass and strength are expected with aging, but physical inactivity and low protein intake have been suggested as risk factors of sarcopenia. So far, lifestyle interventions, especially exercise and nutritional supplementation, prevail as mainstays of treatment for sarcopenia.

Objective: To explore the effect and benefits of protein supplementation on the improvement of muscle mass and physical performance in older people with sarcopenia.

Design: A randomized, double-blind, placebo-controlled clinical trial. Methods: Participants aged 65-95y who meet the following criteria will be invited: (1) muscle mass: bioimpedance, \<7.0 kg/m² (male) and \<5.7 kg/m² (female), (2) handgrip strength: \<28 kg (male) and \<18 kg (female), and (3) low physical performance: 6-m gait Speed \<1.0 m/s. Study participants will be randomly assigned to two groups. The experimental group will receive a 12-week intervention with【protein (14g)+ BCAA(4.4g)】 drink per day, while the parallel control group will receive a placebo oat drink per day.

Participants in the control group will be asked to maintain participants' usual diet and physical activity. There are 3 time-points to measure outcomes and observe other required information, at week 0(baseline), 6 and 12.

Conditions

Interventions

DIETARY_SUPPLEMENT

Protein supplementation

The experimental group contained 14g protein, 0.6g fat, 7g carbohydrate, 4.4 g BCAA , 2.4g glutamate, 0.5g arginine and 0.4g taurine with 90 kcal/pack (Affix Health, Taiwan Branch).

DIETARY_SUPPLEMENT

Placebo oat drink

placebo oat drink contained 1.5g protein, 0.5g fat, 0.1g carbohydrate with 8.3kcal/pack (Zhan Xuan, Co. Ltd., Taiwan).

Sponsors & Collaborators

  • Asia University

    lead OTHER

Principal Investigators

  • Chang · Ching Kuo Institute of Management and Health, Keelung, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-24
Primary Completion
2021-06-30
Completion
2022-06-30

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516421 on ClinicalTrials.gov