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Nutritional Intervention for Sarcopenia

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Branched Chain Amino Acid
Sponsored by
Chimei Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    March 3, 2019
    Last Updated
    March 25, 2019
    Sponsor
    Chimei Medical Center
    Collaborators
    The Taiwanese Osteoporosis Association.
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    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

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    Nutritional Intervention for Sarcopenia

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