Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07309120

Enrollment

Registered

2025-12-30

Start date

2021-12-24

Completion date

2023-06-20

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Muscle Mass, Low Muscle Strength, Low Physical Function

Keywords

metabolomics, supplemenation, pre-sarcopenia

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTParticipants 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Appendicular Skeletal Muscle Index (ASMI)	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).
Handgrip Strength (HGS)	Baseline and 12 weeks after intervention	Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer.
Gait speed (m/s)	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).

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026