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

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

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Dietary supplement: milk supplement; Behavioral: resistance exercise; Dietary supplement: soy milk supplement

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Taipei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 99 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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); Behavioral: resistance exercise; The participants joined the resistance exercise training program, three times per week (30 min/time)
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.	Behavioral: resistance exercise; 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)
PLACEBO_COMPARATOR: control; The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks.	Behavioral: resistance exercise; The participants joined the resistance exercise training program, three times per week (30 min/time)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Taipei Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 24, 2017
• Primary Completion (ACTUAL): January 23, 2018
• Study Completion (ACTUAL): March 23, 2018

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (ACTUAL): September 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: resistance exercise; sarcopenia; milk; soy milk
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: N201702034

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No