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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: January 23, 2018

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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.
  • Placebo Comparator: control
    • The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Taipei Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jiun-Rong Chen, Professor – Taipei Medical University

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