Nutritional Intervention for Sarcopenia
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|ClinicalTrials.gov Identifier: NCT03891134|
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sarcopenia||Dietary Supplement: Branched Chain Amino Acid||Not Applicable|
Sarcopenia is the progressive loss of skeletal muscle that comes with aging. The population in the World Health Organization (WHO) is ageing rapidly and the proportion of people aged 65 and older will get forecast to increase 25% in 2050. In aging society, sarcopenia has been valued in countries all over the world. The appearance of sarcopenia is associated with decreased physical function, falls, fractures, disability, hospitalization, and poor quality of life. Constipation is a common healthy problem. Similar mechanism and risk factors between sarcopenia and constipation are observed with the association of nutrition, but the interrelationships between them is rarely studied.
Prevention and treatment of sarcopenia is more and more important in the health care. Exercise has positive effects in muscle mass and strength but frail elder can't perform exactly. In addition, dietary intervention is one of the major key to reduce the rate of muscle mass loss and maintain physical performance and function.
Recent studies have found that daily and/or supplemental protein is effective prevention of sarcopenia. Protein is composed of amino acids that can induce a muscle protein anabolic response conditioned by the availability of branched-chain amino acids (such as leucine, isoleucine, valine). Delayed amino acid absorption and anabolic resistance are frequently noted among elderly. Branched chain amino acid (BCAA) or leucine supplementation stimulates muscle protein synthesis.
The recommendation about nutrition for preventing sarcopenia was still inconsistent. The time of study for muscle parameter improvement varies from three days to seven days. At present, there is no consensus about the optimal type of nutritional supplements and hint of how long does nutrition take.
The aim of the present study is to evaluate the influence of enriched BCAA on those people with pre-sarcopenia or sarcopenia. The hypothesis is that subjects after enriched-BCAA supplement improves their physical function, muscle strength, and muscle mass. Subsequently, when dis-continued enriched-BCAA muscle-related outcomes would decline.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||630 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||quasi-experimental design|
|Masking:||None (Open Label)|
|Official Title:||Associated Risk Factors and Effect of Nutritional Intervention for Sarcopenia and Constipation in Middle-Aged and Old People|
|Actual Study Start Date :||December 12, 2016|
|Actual Primary Completion Date :||February 6, 2017|
|Actual Study Completion Date :||June 8, 2017|
Experimental: enriched Branched Chain Amino Acid intervention
enriched Branched Chain Amino Acid nutrition supplement 3.6 g twice a day for 5 weeks then withdrawal nutrition supplement for 12 weeks
Dietary Supplement: Branched Chain Amino Acid
Participants were purposively sampled to receive one sachet enriched BCAA twice a day(7.2g) for 5 weeks.
- Skeletal muscle mass index [ Time Frame: 0 week ]Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
- Skeletal muscle mass index [ Time Frame: 5 weeks ]Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
- Skeletal muscle mass index [ Time Frame: 17 weeks ]Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
- Handgrip [ Time Frame: 0 weeks ]Grip strength was measured by Grip-D; TKK 5401
- Handgrip [ Time Frame: 5 weeks ]Grip strength was measured by Grip-D; TKK 5401
- Handgrip [ Time Frame: 17 weeks ]Grip strength was measured by Grip-D; TKK 5401
- 6-meter gait speed [ Time Frame: 0 weeks ]Measure walking speed of six meters
- 6-meter gait speed [ Time Frame: 5 weeks ]Measure walking speed of six meters
- 6-meter gait speed [ Time Frame: 17 weeks ]Measure walking speed of six meters