Assessment of the Intervention Effectiveness of Branched-chain Amino Acids(BCAA) Combined With Medium-chain Fatty Acid(MCFA) Products in Sarcopenia Among Middle-aged and Elderly Individuals

Not Applicable

Recruiting

• Conditions: Sarcopenia

• Registration Number: NCT06376266
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.

Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.

Detailed Description

Project Rationale:

Taiwan entered an aging society in 2018 and is expected to transition into a super-aged society by 2025. With the increasing elderly population, age-related diseases pose urgent challenges to modern society. According to the Ministry of Health and Welfare's National Health Statistics in 2018, the prevalence of sarcopenia in Taiwan among individuals aged 65 and older is 23.6% for males and 18.6% for females. Sarcopenia, characterized by the loss of skeletal muscle mass due to aging, coupled with decreased muscle strength and/or reduced physical performance, poses a significant risk for disability, decreased quality of life, and increased mortality.

Existing research indicates that appropriate nutrition and exercise can slow the onset of sarcopenia and even increase muscle mass to reverse its effects. This study is an interventional clinical trial recruiting middle-aged and elderly patients with sarcopenia or pre-sarcopenia. The intervention involves a combination of branched-chain amino acids and medium-chain triglyceride products, and the study aims to assess the effectiveness of this intervention for sarcopenia in middle-aged and elderly individuals.

Project Objectives:

Evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products as an intervention for sarcopenia in middle-aged and elderly individuals.

Methods:

The study cohort will be recruited from National Taiwan University Hospital, targeting individuals aged 50 and above with sarcopenia or pre-sarcopenia. Randomized double-blind allocation will divide participants into intervention and control groups, with each group recruiting 40 subjects (80 participants in total). The intervention group will receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides, while the control group will be given maltodextrin of the same packaging and quantity as a placebo.

The study will assess various physiological parameters and functional fitness items, conducting the same tests after an 8-week period to evaluate the effectiveness of branched-chain amino acids combined with medium-chain triglyceride products for sarcopenia intervention in middle-aged and elderly individuals.

Expected Outcomes:

Confirmation of the efficacy of nutritional supplements primarily consisting of branched-chain amino acids and medium-chain triglycerides in intervening in muscle loss and promoting daily life functionality in middle-aged and elderly individuals.

Enhanced understanding of the etiology, diagnosis, and assessment methods of sarcopenia among participating staff.

The study anticipates no patent or other commercial interests. If there are any research developments, they will be owned by National Taiwan University Hospital, with potential applications such as publishing academic papers or technology transfer in the future.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2023-12-29
• Status Verified: 2024-01
• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Age ≥ 50 years
• Diagnosis of sarcopenia or pre-sarcopenia

Exclusion Criteria

• Lack of willingness to participate
• Complete dependence on activities of daily living
• Diagnosis of cancer
• Physician-determined life expectancy of less than two years
• Deemed incapable of undergoing assessment by a physician or clinical assessor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
the scale of sarcopenia	Baseline, 8 weeks	physical performance: During testing, participants are required to cross their arms across their chests and record the time (seconds) taken to perform five consecutive sit-to-stand movements and their walking speed (m/s) over a distance of 6 meters.

Trial Locations

Locations (1)

Department of Geriatrics and Gerontology, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan