Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

January 6, 2026 updated by: Chang Gung Memorial Hospital
This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Guishan
      • Taoyuan District, Guishan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Willing to provide written informed consent.
  2. Participants who attend health check-ups at Songshan District, Taipei City, or at the Wellness Cultural Village, or who have participated in the pilot study.
  3. Adults aged 60 years or older, male or female.
  4. Able to ambulate independently.
  5. Meets at least one of the following sarcopenia criteria:

Grip strength: Men < 28 kg; Women < 18 kg Gait speed: < 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men < 7.0 kg/m²; Women < 5.7 kg/m²

Exclusion Criteria:

  1. Impaired renal function.
  2. Allergy or intolerance to protein supplements.
  3. Currently undergoing cancer treatment.
  4. Autoimmune diseases.
  5. Assessed by a physician as unsuitable to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Protein Supplementation Group
Dietary supplement: Participants consume two sachets daily over a 12-week intervention period.
Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Appendicular Skeletal Muscle Index (ASMI)
Time Frame: Baseline and 12 weeks after intervention
Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²).
Baseline and 12 weeks after intervention
Handgrip Strength (HGS)
Time Frame: Baseline and 12 weeks after intervention
Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.
Baseline and 12 weeks after intervention
Gait speed (m/s)
Time Frame: Baseline and 12 weeks after intervention
Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s).
Baseline and 12 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2021

Primary Completion (Actual)

May 31, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Estimated)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 202100551A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical and privacy considerations, individual participant data will not be publicly available. De-identified data may be shared upon reasonable request and with approval from the institutional review board.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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