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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

Tracking Information
First Submitted Date  ICMJE March 3, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE December 12, 2016
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nutritional Intervention for Sarcopenia
Official Title  ICMJE Associated Risk Factors and Effect of Nutritional Intervention for Sarcopenia and Constipation in Middle-Aged and Old People
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
quasi-experimental design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sarcopenia
Intervention  ICMJE Dietary Supplement: Branched Chain Amino Acid
Participants were purposively sampled to receive one sachet enriched BCAA twice a day(7.2g) for 5 weeks.
Study Arms  ICMJE 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
Intervention: Dietary Supplement: Branched Chain Amino Acid
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 25, 2019)
630
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 8, 2017
Actual Primary Completion Date February 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03891134
Other Study ID Numbers  ICMJE CMMC10504-J01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chimei Medical Center
Study Sponsor  ICMJE Chimei Medical Center
Collaborators  ICMJE The Taiwanese Osteoporosis Association.
Investigators  ICMJE Not Provided
PRS Account Chimei Medical Center
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP