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OpenTrials
Completed

NCT Number: NCT07309120

Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

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.

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Key information

Conditions

Low Muscle Mass Low Muscle Strength Low Physical Function

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, Guishan, 333, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to provide written informed consent.
  • 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.
  • Adults aged 60 years or older, male or female.
  • Able to ambulate independently.
  • 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

  • Impaired renal function.
  • Allergy or intolerance to protein supplements.
  • Currently undergoing cancer treatment.
  • Autoimmune diseases.
  • Assessed by a physician as unsuitable to participate.

Treatment and study plan

Participants consume two sachets daily over a 12-week intervention period.

Dietary Supplement

Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates.

Primary outcomes

  1. 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).

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2025
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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