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

NCT06376266 | Completed

• 1 other identifier: 202305083RSC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; branched-chain amino acids(BCAA); medium-chain fatty acid(MCFA)

Outcome Measures

Primary Outcomes (3)

• the scale of sarcopenia

  muscle mass: this study utilizes BIA or DXA to measure the ASMI (kg/ht\^2)

  Baseline, 8 weeks

• the scale of sarcopenia

  muscle strength: Use a handgrip dynamometer to measure the dominant hand grip strength (kgw) of the participants. Take the maximum value of three measurements, with a one-minute interval between each measurement.

  Baseline, 8 weeks

• the scale of sarcopenia

  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.

  Baseline, 8 weeks

Study Arms (2)

receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides

ACTIVE COMPARATOR

receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides

Combination Product: nutritional supplements

receive a daily supplement of maltodextrin of the same packaging and quantity

PLACEBO COMPARATOR

receive a daily supplement of maltodextrin of the same packaging and quantity

Combination Product: nutritional supplements

Interventions

nutritional supplements COMBINATION_PRODUCT

a daily supplement of branched-chain amino acids combined with medium-chain triglycerides

receive a daily supplement of branched-chain amino acids combined with medium-chain triglycerides; receive a daily supplement of maltodextrin of the same packaging and quantity

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Geriatrics and Gerontology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ding-cheng Chan, Dr

  Department of Geriatrics and Gerontology, National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: April 19, 2024
• Study Start: October 1, 2023
• Primary Completion: December 29, 2023
• Study Completion: September 30, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)