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Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.

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ClinicalTrials.gov Identifier: NCT05035121
Recruitment Status : Completed
First Posted : September 5, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jiun-Rong Chen, Taipei Medical University

Tracking Information
First Submitted Date  ICMJE May 24, 2021
First Posted Date  ICMJE September 5, 2021
Last Update Posted Date September 5, 2021
Actual Study Start Date  ICMJE March 24, 2017
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • appendicular skeletal muscle mass in kilograms [ Time Frame: baseline ]
    The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
  • Change from baseline appendicular skeletal muscle mass at 6 weeks [ Time Frame: 6 weeks ]
    The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
  • Change from baseline appendicular skeletal muscle mass at 12 weeks [ Time Frame: 12 weeks ]
    The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
  • height in meters [ Time Frame: baseline ]
    Height was measured by height meter
  • Change baseline weeks height at 6 weeks [ Time Frame: 6 weeks ]
    Height was measured by height meter
  • Change from baseline height at 12 weeks [ Time Frame: 12 weeks ]
    Height was measured by height meter
  • appendicular skeletal muscle mass index in kg/m^2 [ Time Frame: baseline ]
    The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
  • Change from baseline appendicular skeletal muscle mass index at 6 weeks [ Time Frame: 6 weeks ]
    The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
  • Change from baseline appendicular skeletal muscle mass index at 12 weeks [ Time Frame: 12 weeks ]
    The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
  • calf circumferences in centimeter [ Time Frame: baseline ]
    calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
  • Change from baseline calf circumferences at 6 weeks [ Time Frame: 6 weeks ]
    calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
  • Change from baseline calf circumferences at 12 weeks [ Time Frame: 12 weeks ]
    calf circumferences (cm) was measured by using a measuring tape to go around the thickest point of the calf and stick tightly without squeezing the skin.
  • hand grip in kilograms [ Time Frame: baseline ]
    The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
  • Change from baseline hand grip at 6 weeks [ Time Frame: 6 weeks ]
    The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
  • Change from baseline hand grip at 12 weeks [ Time Frame: 12 weeks ]
    The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
  • gait speed in meter per second [ Time Frame: baseline ]
    The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
  • Change from baseline gait speed at 6 weeks [ Time Frame: 6 weeks ]
    The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
  • Change from baseline gait speed at 12 weeks [ Time Frame: 12 weeks ]
    The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2021)
  • blood alanine transaminase activity in U/L [ Time Frame: baseline ]
    The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer.
  • Change from baseline blood alanine transaminase activity at 12 weeks [ Time Frame: 12 weeks ]
    The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer.
  • blood creatinine level in mg/dL [ Time Frame: baseline ]
    The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
  • Change from baseline blood creatinine level at 12 weeks [ Time Frame: 12 weeks ]
    The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
  • blood prealbumin level in mg/dL [ Time Frame: baseline ]
    The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer.
  • Change from baseline blood prealbumin level at 12 weeks [ Time Frame: 12 weeks ]
    The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer.
  • blood 25-hydroxyvitamin D level in ng/mL [ Time Frame: baseline ]
    The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer.
  • Change from baseline blood 25-hydroxyvitamin D level at 12 weeks [ Time Frame: 12 weeks ]
    The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer.
  • High sensitive C-reactive protein in mg/dL [ Time Frame: baseline ]
    High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer.
  • Change from baseline High sensitive C-reactive protein at 12 weeks [ Time Frame: 12 weeks ]
    High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer.
  • blood fasting blood sugar in mg/dL [ Time Frame: baseline ]
    The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer.
  • Change from baseline blood fasting blood sugar at 12 weeks [ Time Frame: 12 weeks ]
    The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer.
  • blood insulin level in milli-international unit/L [ Time Frame: baseline ]
    The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits.
  • Change from baseline blood insulin level at 12 weeks [ Time Frame: 12 weeks ]
    The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits.
  • blood HbA1c in percentage [ Time Frame: baseline ]
    The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.
  • Change from baseline blood HbA1c at 12 weeks [ Time Frame: 12 weeks ]
    The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.
  • Homeostasis model assessment-insulin resistance index (HOMA-IR) [ Time Frame: baseline ]
    HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5
  • Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks [ Time Frame: 12 weeks ]
    HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5
  • blood insulin-like growth factor 1 in mg/dL [ Time Frame: baseline ]
    The blood insulin-like growth factor 1 (IGF-1) level considered to be related with the protein synthesis in muscle was measured by chemiluminescence immunoassay.
  • Change from baseline blood insulin-like growth factor 1 at 12 weeks [ Time Frame: 12 weeks ]
    The blood insulin-like growth factor 1 (IGF-1) level considered to be related with the protein synthesis in muscle was measured by chemiluminescence immunoassay.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2021)
  • diet assessment [ Time Frame: baseline ]
    Dietary data were collected based on the meal menu of the nursing home including one weekday and two weekends at the beginning and the end of the experiment. Caregivers recorded the actual food intake by participants. The intake of total energy, carbohydrate, protein and fat was analyzed with E Kitchen Nutrients Analysis Software (E Kitchen Business, Taichung, Taiwan) based on the food and nutrient database created by the Organization Act of the Food and Drug Administration, Ministry of Health and Welfare, Taiwan.
  • Change from baseline diet assessment at 12 weeks [ Time Frame: 12 weeks ]
    Dietary data were collected based on the meal menu of the nursing home including one weekday and two weekends at the beginning and the end of the experiment. Caregivers recorded the actual food intake by participants. The intake of total energy, carbohydrate, protein and fat was analyzed with E Kitchen Nutrients Analysis Software (E Kitchen Business, Taichung, Taiwan) based on the food and nutrient database created by the Organization Act of the Food and Drug Administration, Ministry of Health and Welfare, Taiwan.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.
Official Title  ICMJE Effects of Milk or Soy Milk Combined With Mild Resistance Exercise on the Muscle Mass and Muscle Strength in Very Old Nursing Home Residents With Sarcopenia
Brief Summary The purpose of this study was determine whether milk or soy milk supplements combined with resistance exercise improved sarcopenia in the elderly. This study was randomized controlled trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of Taipei Veterans General Hospital Su-Ao and Yuanshan Branch from June 2017 to December, 2017. The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30 min/time). After 12 weeks, the anthropometry, sarcopenia index, blood biochemical index, nutrition status index, inflammation index, insulin resistance index, and dietary intake were measured.
Detailed Description The anthropometry data included body weight and body fat. The sarcopenia index included appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed. Moreover, blood biochemical index (liver function as ALT, kidney function as creatinine), nutrition status index (prealbumin, 25-hydroxyvitamin D) were also analyzed. The blood hsCRP level was as inflammation index and insulin resistance index included fasting blood sugar, insulin, HbA1c and HOMA-IR. The daily dietary intake were also recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The participants were divided into three groups, such as control, milk supplement and soy milk supplement. The milk and soy milk groups provided 200 mL milk or soy milk two times per day. Moreover, all participants joined the resistance exercise training program, three times per week (30min/time).
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Sarcopenia
Intervention  ICMJE
  • Dietary Supplement: milk supplement
    Intervention groups provided 200 mL long life milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)
  • Dietary Supplement: soy milk supplement
    Intervention groups provided 200 mL long life soy milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)
  • Behavioral: resistance exercise
    The participants joined the resistance exercise training program, three times per week (30 min/time)
Study Arms  ICMJE
  • Experimental: milk supplement
    The milk group provided 200 mL milk two times per day. The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.
    Interventions:
    • Dietary Supplement: milk supplement
    • Behavioral: resistance exercise
  • Experimental: soy milk supplement
    The soy milk group provided 200 mL soy milk two times per day. The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.
    Interventions:
    • Dietary Supplement: soy milk supplement
    • Behavioral: resistance exercise
  • Placebo Comparator: control
    The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.
    Intervention: Behavioral: resistance exercise
Publications * Not Provided

*   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: August 31, 2021)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 23, 2018
Actual Primary Completion Date January 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≧ 65 years old
  • No allergies to milk and soy milk
  • Sarcopenia cases (AWGS)
  • Active ability

Exclusion Criteria:

  • End-of-life patient or estimated death within six months
  • Last stage of cancer
  • Chronic kidney disease stage 4
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 99 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05035121
Other Study ID Numbers  ICMJE N201702034
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Jiun-Rong Chen, Taipei Medical University
Study Sponsor  ICMJE Taipei Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Taipei Medical University
Verification Date August 2021

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