Clinical trial NCT05035121: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
milk
soy milk
resistance exercise
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 35
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: appendicular skeletal muscle mass in kilograms
timeFrame: baseline
measure: Change from baseline appendicular skeletal muscle mass at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline appendicular skeletal muscle mass at 12 weeks
timeFrame: 12 weeks
measure: height in meters
timeFrame: baseline
measure: Change baseline weeks height at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline height at 12 weeks
timeFrame: 12 weeks
measure: appendicular skeletal muscle mass index in kg/m^2
timeFrame: baseline
measure: Change from baseline appendicular skeletal muscle mass index at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline appendicular skeletal muscle mass index at 12 weeks
timeFrame: 12 weeks
measure: calf circumferences in centimeter
timeFrame: baseline
measure: Change from baseline calf circumferences at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline calf circumferences at 12 weeks
timeFrame: 12 weeks
measure: hand grip in kilograms
timeFrame: baseline
measure: Change from baseline hand grip at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline hand grip at 12 weeks
timeFrame: 12 weeks
measure: gait speed in meter per second
timeFrame: baseline
measure: Change from baseline gait speed at 6 weeks
timeFrame: 6 weeks
measure: Change from baseline gait speed at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: blood alanine transaminase activity in U/L
timeFrame: baseline
measure: Change from baseline blood alanine transaminase activity at 12 weeks
timeFrame: 12 weeks
measure: blood creatinine level in mg/dL
timeFrame: baseline
measure: Change from baseline blood creatinine level at 12 weeks
timeFrame: 12 weeks
measure: blood prealbumin level in mg/dL
timeFrame: baseline
measure: Change from baseline blood prealbumin level at 12 weeks
timeFrame: 12 weeks
measure: blood 25-hydroxyvitamin D level in ng/mL
timeFrame: baseline
measure: Change from baseline blood 25-hydroxyvitamin D level at 12 weeks
timeFrame: 12 weeks
measure: High sensitive C-reactive protein in mg/dL
timeFrame: baseline
measure: Change from baseline High sensitive C-reactive protein at 12 weeks
timeFrame: 12 weeks
measure: blood fasting blood sugar in mg/dL
timeFrame: baseline
measure: Change from baseline blood fasting blood sugar at 12 weeks
timeFrame: 12 weeks
measure: blood insulin level in milli-international unit/L
timeFrame: baseline
measure: Change from baseline blood insulin level at 12 weeks
timeFrame: 12 weeks
measure: blood HbA1c in percentage
timeFrame: baseline
measure: Change from baseline blood HbA1c at 12 weeks
timeFrame: 12 weeks
measure: Homeostasis model assessment-insulin resistance index (HOMA-IR)
timeFrame: baseline
measure: Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks
timeFrame: 12 weeks
measure: blood insulin-like growth factor 1 in mg/dL
timeFrame: baseline
measure: Change from baseline blood insulin-like growth factor 1 at 12 weeks
timeFrame: 12 weeks
Other outcomes:
measure: diet assessment
timeFrame: baseline
measure: Change from baseline diet assessment at 12 weeks
timeFrame: 12 weeks
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University
Study officials:
References: