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Completed

NCT Number: NCT05035121

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

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.

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Key information

Conditions

Sarcopenia Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Medical University

New Taipei City, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

milk supplement

Dietary 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)

soy milk supplement

Dietary 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)

Resistance exercise

Behavioral

The participants joined the resistance exercise training program, three times per week (30 min/time)

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. height in meters

    Time frame: baseline

    Height was measured by height meter

  5. Change baseline weeks height at 6 weeks

    Time frame: 6 weeks

    Height was measured by height meter

  6. Change from baseline height at 12 weeks

    Time frame: 12 weeks

    Height was measured by height meter

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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)

  14. 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)

  15. 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)

  16. 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.

  17. 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.

  18. 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 outcomes

  1. 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.

  2. 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.

  3. blood creatinine level in mg/dL

    Time frame: baseline

    The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. blood HbA1c in percentage

    Time frame: baseline

    The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2021
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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