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

NCT ID: NCT06991855

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-04-17

Brief Summary

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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.

Detailed Description

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Conditions

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Sarcopenia Sarcopenia in Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Animal-Based Oil Group

Participants in this group will supplement with animal-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks.

Group Type EXPERIMENTAL

Animal-Based Oil Group

Intervention Type 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

Participants in this group will supplement with plant-based poly-unsaturated oil. The supplementation will be maintained for 12 weeks.

Group Type EXPERIMENTAL

Plant-Based Oil Group

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung University

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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JI-TSENG FANG

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chang Gung Memorial Hospital

Linkou District, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hsiang-Yu Tang, Ph.D.

Role: CONTACT

+886-3-2118800 ext. 3650

Yi Tsang Chen, Master of Science

Role: CONTACT

+886-2-2712-2211 ext. 7358

Facility Contacts

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Yi-Tsang Chen

Role: primary

+886-2-2712-2211 ext. 7358

Other Identifiers

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202500394A3

Identifier Type: -

Identifier Source: org_study_id

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