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NCT Number: NCT06991855

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia in Elderly Signs and Symptoms

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Linkou District, 333, Taiwan

Location status: Recruiting

Location contact

Yi-Tsang Chen

CONTACT

[email protected]

+886-2-2712-2211 ext. 7358

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animal-Based Oil Group

Dietary Supplement

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.

Plant-Based Oil Group

Dietary Supplement

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 outcomes

  1. muscle mass

    Time frame: baseline, 12 weeks

    Utilize Bioelectrical Impedance Analysis (BIA) to measure the Appendicular Skeletal Muscle Mass Index Level (ASMI) (kg/m^2)

  2. muscle function

    Time frame: baseline, 12 weeks

    utilize handgrip dynamometer to measure the hand grip strength (kg).

  3. physical function

    Time frame: baseline, 12 weeks

    To assess the participant's walking speed over a 4-meter distance.

Study contacts

Contact information is provided by the study sponsor or research team.

Hsiang-Yu Tang, Ph.D.

CONTACT

[email protected]

+886-3-2118800 ext. 3650

Yi Tsang Chen, Master of Science

CONTACT

[email protected]

+886-2-2712-2211 ext. 7358

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Chang Gung University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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