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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sarcopenia

Intervention / Treatment
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* Dietary Supplement: milk supplement
* Dietary Supplement: soy milk supplement
* Behavioral: resistance exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: milk supplement<br>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. | Dietary Supplement: milk supplement<br>* 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)<br>Behavioral: resistance exercise<br>* The participants joined the resistance exercise training program, three times per week (30 min/time)<br>|
| Experimental: soy milk supplement<br>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. | Dietary Supplement: soy milk supplement<br>* 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)<br>Behavioral: resistance exercise<br>* The participants joined the resistance exercise training program, three times per week (30 min/time)<br>|
| Placebo Comparator: control<br>The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks. | Behavioral: resistance exercise<br>* The participants joined the resistance exercise training program, three times per week (30 min/time)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| appendicular skeletal muscle mass in kilograms | The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea) | baseline | 
| Change from baseline appendicular skeletal muscle mass at 6 weeks | The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea) | 6 weeks | 
| Change from baseline appendicular skeletal muscle mass at 12 weeks | The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea) | 12 weeks | 
| height in meters | Height was measured by height meter | baseline | 
| Change baseline weeks height at 6 weeks | Height was measured by height meter | 6 weeks | 
| Change from baseline height at 12 weeks | Height was measured by height meter | 12 weeks | 
| appendicular skeletal muscle mass index in kg/m^2 | The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2. | baseline | 
| Change from baseline appendicular skeletal muscle mass index at 6 weeks | The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2. | 6 weeks | 
| Change from baseline appendicular skeletal muscle mass index at 12 weeks | The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2. | 12 weeks | 
| calf circumferences in centimeter | 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. | baseline | 
| Change from baseline calf circumferences at 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. | 6 weeks | 
| Change from baseline calf circumferences at 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. | 12 weeks | 
| hand grip in kilograms | The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan) | baseline | 
| Change from baseline hand grip at 6 weeks | The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan) | 6 weeks | 
| Change from baseline hand grip at 12 weeks | The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan) | 12 weeks | 
| gait speed in meter per second | The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second. | baseline | 
| Change from baseline gait speed at 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. | 6 weeks | 
| Change from baseline gait speed at 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood alanine transaminase activity in U/L | The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood alanine transaminase activity at 12 weeks | The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer. | 12 weeks | 
| blood creatinine level in mg/dL | The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood creatinine level at 12 weeks | The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer. | 12 weeks | 
| blood prealbumin level in mg/dL | The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood prealbumin level at 12 weeks | The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer. | 12 weeks | 
| blood 25-hydroxyvitamin D level in ng/mL | The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood 25-hydroxyvitamin D level at 12 weeks | The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer. | 12 weeks | 
| High sensitive C-reactive protein in mg/dL | High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer. | baseline | 
| Change from baseline High sensitive C-reactive protein at 12 weeks | High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer. | 12 weeks | 
| blood fasting blood sugar in mg/dL | The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood fasting blood sugar at 12 weeks | The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer. | 12 weeks | 
| blood insulin level in milli-international unit/L | The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits. | baseline | 
| Change from baseline blood insulin level at 12 weeks | The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits. | 12 weeks | 
| blood HbA1c in percentage | The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer. | baseline | 
| Change from baseline blood HbA1c at 12 weeks | The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer. | 12 weeks | 
| Homeostasis model assessment-insulin resistance index (HOMA-IR) | HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5 | baseline | 
| Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks | HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5 | 12 weeks | 
| blood insulin-like growth factor 1 in mg/dL | 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. | baseline | 
| Change from baseline blood insulin-like growth factor 1 at 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, milk, soy milk, resistance exercise