Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
Explore the Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly
1 other identifier
interventional
90
1 country
1
Brief Summary
Population aging has become a significant global concern, and Taiwan is set to officially enter the "super-aged society" in 2025. As individuals age, various physiological functions gradually decline, including a reduction in muscle mass, which is a key aspect of the aging process. This interventional study aims to investigate the effects of leucine-rich protein combined with polyunsaturated fatty acid supplementation on middle-aged and elderly individuals (aged 50 and above) who are at high risk for sarcopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2025
CompletedFirst Posted
Study publicly available on registry
May 28, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 10, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2026
CompletedJune 22, 2025
June 1, 2025
9 months
May 27, 2025
June 19, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
muscle mass
Utilize Bioelectrical Impedance Analysis (BIA) to measure the Appendicular Skeletal Muscle Mass Index Level (ASMI) (kg/m\^2)
baseline, 12 weeks
muscle function
utilize handgrip dynamometer to measure the hand grip strength (kg).
baseline, 12 weeks
physical function
To assess the participant's walking speed over a 4-meter distance.
baseline, 12 weeks
Study Arms (2)
Animal-Based Oil Group
EXPERIMENTALParticipants in this group will supplement with animal-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks.
Plant-Based Oil Group
EXPERIMENTALParticipants in this group will supplement with plant-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks.
Interventions
Participants in animal-based oil group will follow a diet in which the primary fat source is animal-based oil. The diet will supplement for 12 weeks.
Participants in plant-based oil group will follow a diet in which the primary fat source is plant-based oil. The diet will supplement for 12 weeks.
Eligibility Criteria
You may qualify if:
- Age ≥ 50 years
- ASMI \< 7 kg/m2 in men
- ASMI \< 5.7 kg/m2 in women
- Grip strength \< 28 kg in men
- Grip strength \< 18 kg in women
- Walk speed \< 1 m/s
You may not qualify if:
- People who are allergic to supplements
- cancer
- heart failure
- kidney disease
- autoimmune disease
- neurodegenerative disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chang Gung Memorial Hospitallead
- Chang Gung Universitycollaborator
Study Sites (1)
Chang Gung Memorial Hospital
Linkou District, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 27, 2025
First Posted
May 28, 2025
Study Start
July 1, 2025
Primary Completion
April 10, 2026
Study Completion
April 17, 2026
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share