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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05035121
Other study ID # N201702034
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 24, 2017
Est. completion date March 23, 2018

Study information

Verified date August 2021
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date March 23, 2018
Est. primary completion date January 23, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 99 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)
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)

Locations

Country Name City State
Taiwan Taipei Medical University New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other diet assessment 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. baseline
Other Change from baseline diet assessment at 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. 12 weeks
Primary 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
Primary 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
Primary 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
Primary height in meters Height was measured by height meter baseline
Primary Change baseline weeks height at 6 weeks Height was measured by height meter 6 weeks
Primary Change from baseline height at 12 weeks Height was measured by height meter 12 weeks
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary blood creatinine level in mg/dL The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer. baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary blood HbA1c in percentage The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer. baseline
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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