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

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
milk supplement
soy milk supplement
resistance exercise
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring sarcopenia, milk, soy milk, resistance exercise

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

milk supplement

soy milk supplement

control

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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)
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)
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)
height in meters
Height was measured by height meter
Change baseline weeks height at 6 weeks
Height was measured by height meter
Change from baseline height at 12 weeks
Height was measured by height meter
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.
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.
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.
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.
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.
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.
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)
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)
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)
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.
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.
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.

Secondary Outcome Measures

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.
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.
blood creatinine level in mg/dL
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
Change from baseline blood creatinine level at 12 weeks
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
blood HbA1c in percentage
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
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)
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
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
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
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.

Full Information

First Posted
May 24, 2021
Last Updated
August 31, 2021
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05035121
Brief Title
Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
sarcopenia, milk, soy milk, resistance exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
milk supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
soy milk supplement
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
milk supplement
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
soy milk supplement
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
resistance exercise
Intervention Description
The participants joined the resistance exercise training program, three times per week (30 min/time)
Primary Outcome Measure Information:
Title
appendicular skeletal muscle mass in kilograms
Description
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Time Frame
baseline
Title
Change from baseline appendicular skeletal muscle mass at 6 weeks
Description
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Time Frame
6 weeks
Title
Change from baseline appendicular skeletal muscle mass at 12 weeks
Description
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
Time Frame
12 weeks
Title
height in meters
Description
Height was measured by height meter
Time Frame
baseline
Title
Change baseline weeks height at 6 weeks
Description
Height was measured by height meter
Time Frame
6 weeks
Title
Change from baseline height at 12 weeks
Description
Height was measured by height meter
Time Frame
12 weeks
Title
appendicular skeletal muscle mass index in kg/m^2
Description
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
Time Frame
baseline
Title
Change from baseline appendicular skeletal muscle mass index at 6 weeks
Description
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
Time Frame
6 weeks
Title
Change from baseline appendicular skeletal muscle mass index at 12 weeks
Description
The appendicular skeletal muscle mass muscle mass and height was combined to report appendicular skeletal muscle mass index in kg/m^2.
Time Frame
12 weeks
Title
calf circumferences in centimeter
Description
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.
Time Frame
baseline
Title
Change from baseline calf circumferences at 6 weeks
Description
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.
Time Frame
6 weeks
Title
Change from baseline calf circumferences at 12 weeks
Description
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.
Time Frame
12 weeks
Title
hand grip in kilograms
Description
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
Time Frame
baseline
Title
Change from baseline hand grip at 6 weeks
Description
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
Time Frame
6 weeks
Title
Change from baseline hand grip at 12 weeks
Description
The muscle strength was evaluated with the hand-grip strength (kg) using a Smedley dynamometer (TTM-YD, Tsutsumi Industries, Tokyo, Japan)
Time Frame
12 weeks
Title
gait speed in meter per second
Description
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
Time Frame
baseline
Title
Change from baseline gait speed at 6 weeks
Description
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
Time Frame
6 weeks
Title
Change from baseline gait speed at 12 weeks
Description
The gait speed test was performed by recording the average time of walking 6 meters and representing with the distance (m) per second.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
blood alanine transaminase activity in U/L
Description
The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood alanine transaminase activity at 12 weeks
Description
The blood alanine transaminase (ALT) activity in U/L was measured as liver function index by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
blood creatinine level in mg/dL
Description
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood creatinine level at 12 weeks
Description
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
blood prealbumin level in mg/dL
Description
The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood prealbumin level at 12 weeks
Description
The blood prealbumin level in mg/dL as the index of nutritional status were measured by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
blood 25-hydroxyvitamin D level in ng/mL
Description
The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood 25-hydroxyvitamin D level at 12 weeks
Description
The blood 25-hydroxyvitamin D level in ng/mL as the index of nutritional status were measured by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
High sensitive C-reactive protein in mg/dL
Description
High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline High sensitive C-reactive protein at 12 weeks
Description
High sensitive C-reactive protein (hsCRP) as the inflammatory indicator were measured by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
blood fasting blood sugar in mg/dL
Description
The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood fasting blood sugar at 12 weeks
Description
The blood fasting blood sugar level in mg/dL as the insulin resistance index was measured by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
blood insulin level in milli-international unit/L
Description
The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits.
Time Frame
baseline
Title
Change from baseline blood insulin level at 12 weeks
Description
The blood insulin level in milli-international unit/L as the insulin resistance index was measured by commercial kits.
Time Frame
12 weeks
Title
blood HbA1c in percentage
Description
The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.
Time Frame
baseline
Title
Change from baseline blood HbA1c at 12 weeks
Description
The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.
Time Frame
12 weeks
Title
Homeostasis model assessment-insulin resistance index (HOMA-IR)
Description
HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5
Time Frame
baseline
Title
Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks
Description
HOMA-IR was calculated according to the formula: fasting insulin (μU/mL) x fasting glucose (mmol/L)/22.5
Time Frame
12 weeks
Title
blood insulin-like growth factor 1 in mg/dL
Description
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.
Time Frame
baseline
Title
Change from baseline blood insulin-like growth factor 1 at 12 weeks
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
diet assessment
Description
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.
Time Frame
baseline
Title
Change from baseline diet assessment at 12 weeks
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Taipei Medical University
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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