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Recruiting NCT06991855

Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly

No phase Interventional Sarcopenia Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Animal-Based Oil Group, Plant-Based Oil Group.
Who it may be relevant to
Registry conditions: Sarcopenia, Sarcopenia in Elderly. Basic parameters: 50 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Explore the Effects of Nutritional Supplementation of Leucine and Polyunsaturated Fatty Acids on Muscle Health in the Elderly

Overview

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.

Interventions

  • Dietary supplement Animal-Based Oil Group
    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.
  • Dietary supplement Plant-Based Oil Group
    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.

Primary outcome measures

  • muscle mass [Time frame: baseline, 12 weeks]
  • muscle function [Time frame: baseline, 12 weeks]
  • physical function [Time frame: baseline, 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • People who are allergic to supplements
  • cancer
  • heart failure
  • kidney disease
  • autoimmune disease
  • neurodegenerative disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung Memorial Hospital — Linkou District

Identifiers

NCT: NCT06991855 · 202500394A3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗