Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly

Chang Gung Medical Foundation

Status: Completed

Conditions: Low Muscle Mass; Low Muscle Strength; Low Physical Function

Treatments: Dietary Supplement: Participants consume two sachets daily over a 12-week intervention period.

Study type: Interventional

Funder types: Other

Identifiers

NCT07309120

202100551A3

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Protein Supplementation Group

Experimental group

Treatment:

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