Nutritional Intervention for Sarcopenia
Primary Purpose
Sarcopenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Branched Chain Amino Acid
Sponsored by
About this trial
This is an interventional treatment trial for Sarcopenia
Eligibility Criteria
Inclusion Criteria:
- over 40 years of age
- generally healthy according to responses to a standard health-screening questionnaire.
Exclusion Criteria:
- uncontrolled hypertension or diabetes
- stroke
- severe liver or renal disease
- gastrointestinal disease
- neuromuscular disease
- infectious disease
- cancer,
- pulmonary disease
- disease of the endocrine system
- history of seizures, neurological or significant psychiatric illness
- sensitivity to study ingredients.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
enriched Branched Chain Amino Acid intervention
Arm Description
enriched Branched Chain Amino Acid nutrition supplement 3.6 g twice a day for 5 weeks then withdrawal nutrition supplement for 12 weeks
Outcomes
Primary Outcome Measures
Skeletal muscle mass index
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Skeletal muscle mass index
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Skeletal muscle mass index
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Handgrip
Grip strength was measured by Grip-D; TKK 5401
Handgrip
Grip strength was measured by Grip-D; TKK 5401
Handgrip
Grip strength was measured by Grip-D; TKK 5401
6-meter gait speed
Measure walking speed of six meters
6-meter gait speed
Measure walking speed of six meters
6-meter gait speed
Measure walking speed of six meters
Secondary Outcome Measures
Full Information
NCT ID
NCT03891134
First Posted
March 3, 2019
Last Updated
March 25, 2019
Sponsor
Chimei Medical Center
Collaborators
The Taiwanese Osteoporosis Association.
1. Study Identification
Unique Protocol Identification Number
NCT03891134
Brief Title
Nutritional Intervention for Sarcopenia
Official Title
Associated Risk Factors and Effect of Nutritional Intervention for Sarcopenia and Constipation in Middle-Aged and Old People
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
February 6, 2017 (Actual)
Study Completion Date
June 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chimei Medical Center
Collaborators
The Taiwanese Osteoporosis Association.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sarcopenia is an age-related poor healthy outcome. nutrition intervention is one , progressive, generalized loss of muscle mass and the decrement in physical activity. Sarcopenia is associated with subsequent health hazards such as disability, falls, functional degeneration, hospitalization and death. There are similar causes between sarcopenia and constipation such as aging, reduced mobility, changes in diet and co-morbidities. Nutrition plays an important role for muscle maintenance. The trial tries to figure out the effect of enriched branched-chain amino acid (BCAA) nutrient on muscle mass, strength and physical performance of sarcopenia in the middle-aged and old people.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi-experimental design
Masking
None (Open Label)
Allocation
N/A
Enrollment
630 (Actual)
8. Arms, Groups, and Interventions
Arm Title
enriched Branched Chain Amino Acid intervention
Arm Type
Experimental
Arm Description
enriched Branched Chain Amino Acid nutrition supplement 3.6 g twice a day for 5 weeks then withdrawal nutrition supplement for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Branched Chain Amino Acid
Intervention Description
Participants were purposively sampled to receive one sachet enriched BCAA twice a day(7.2g) for 5 weeks.
Primary Outcome Measure Information:
Title
Skeletal muscle mass index
Description
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Time Frame
0 week
Title
Skeletal muscle mass index
Description
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Time Frame
5 weeks
Title
Skeletal muscle mass index
Description
Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)
Time Frame
17 weeks
Title
Handgrip
Description
Grip strength was measured by Grip-D; TKK 5401
Time Frame
0 weeks
Title
Handgrip
Description
Grip strength was measured by Grip-D; TKK 5401
Time Frame
5 weeks
Title
Handgrip
Description
Grip strength was measured by Grip-D; TKK 5401
Time Frame
17 weeks
Title
6-meter gait speed
Description
Measure walking speed of six meters
Time Frame
0 weeks
Title
6-meter gait speed
Description
Measure walking speed of six meters
Time Frame
5 weeks
Title
6-meter gait speed
Description
Measure walking speed of six meters
Time Frame
17 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
over 40 years of age
generally healthy according to responses to a standard health-screening questionnaire.
Exclusion Criteria:
uncontrolled hypertension or diabetes
stroke
severe liver or renal disease
gastrointestinal disease
neuromuscular disease
infectious disease
cancer,
pulmonary disease
disease of the endocrine system
history of seizures, neurological or significant psychiatric illness
sensitivity to study ingredients.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12028177
Citation
Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc. 2002 May;50(5):889-96. doi: 10.1046/j.1532-5415.2002.50216.x.
Results Reference
result
Learn more about this trial
Nutritional Intervention for Sarcopenia
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