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Nutritional Intervention for Sarcopenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03891134
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
The Taiwanese Osteoporosis Association.
Information provided by (Responsible Party):
Chimei Medical Center

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.

Condition or disease Intervention/treatment Phase
Sarcopenia Dietary Supplement: Branched Chain Amino Acid Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 630 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: quasi-experimental design
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Skeletal muscle mass index [ Time Frame: 0 week ]
    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

  2. Skeletal muscle mass index [ Time Frame: 5 weeks ]
    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

  3. Skeletal muscle mass index [ Time Frame: 17 weeks ]
    Skeletal muscle mass index was measured by bioelectrical impedance analysis (BC-418, Tanita)

  4. Handgrip [ Time Frame: 0 weeks ]
    Grip strength was measured by Grip-D; TKK 5401

  5. Handgrip [ Time Frame: 5 weeks ]
    Grip strength was measured by Grip-D; TKK 5401

  6. Handgrip [ Time Frame: 17 weeks ]
    Grip strength was measured by Grip-D; TKK 5401

  7. 6-meter gait speed [ Time Frame: 0 weeks ]
    Measure walking speed of six meters

  8. 6-meter gait speed [ Time Frame: 5 weeks ]
    Measure walking speed of six meters

  9. 6-meter gait speed [ Time Frame: 17 weeks ]
    Measure walking speed of six meters



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Publications of Results:
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Responsible Party: Chimei Medical Center
ClinicalTrials.gov Identifier: NCT03891134    
Other Study ID Numbers: CMMC10504-J01
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical