Clinical trial NCT06376266: 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
Official title: Aged and Elderly Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
branched-chain amino acids(BCAA)
medium-chain fatty acid(MCFA)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: the scale of sarcopenia
timeFrame: Baseline, 8 weeks
measure: the scale of sarcopenia
timeFrame: Baseline, 8 weeks
measure: the scale of sarcopenia
timeFrame: Baseline, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Geriatrics and Gerontology, National Taiwan University Hospital
Study officials:
affiliation: Department of Geriatrics and Gerontology, National Taiwan University Hospital
name: Ding-cheng Chan, Dr
role: STUDY_DIRECTOR
References: