Nutrition Ameliorates the Muscle Loss of Pre-sarcopenia in Elderly
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Appendicular Skeletal Muscle Index (ASMI)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Protein Supplementation Group
Intervention: Participants consume two sachets daily over a 12-week intervention period. (Dietary Supplement)
Outcomes
Primary Outcomes
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).
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.
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).
Secondary Outcomes
No secondary outcomes reported