SarcopeniaNCT05035121
Effect of Nutrition Supplementation Combined With Resistance Exercise in Elderly With Sarcopenia.
A study testing milk supplement, soy milk supplement and resistance exercise in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- milk supplement, soy milk supplement and resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Mar 2017to 23 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≧ 65 years old
- No allergies to milk and soy milk
- Sarcopenia cases (AWGS)
- Active ability
Who cannot join
- End-of-life patient or estimated death within six months
- Last stage of cancer
- Chronic kidney disease stage 4
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sarcopenia
- Being tested
- milk supplement, soy milk supplement, resistance exercise
- Keywords
- sarcopenia, milk, soy milk, resistance exercise
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
milk supplementDietary 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 supplementDietary 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)
resistance exerciseBehavioural
The participants joined the resistance exercise training program, three times per week (30 min/time)
| Study group | Role | What they receive |
|---|---|---|
| milk supplement | Experimental | 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. Receives: Dietary Supplement: milk supplement; Behavioral: resistance exercise |
| soy milk supplement | Experimental | 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. Receives: Dietary Supplement: soy milk supplement; Behavioral: resistance exercise |
| control | Placebo comparator | The participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks. Receives: Behavioral: resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 12 weeks
height in meters
Height was measured by height meter
Measured: baseline
Change baseline weeks height at 6 weeks
Height was measured by height meter
Measured: 6 weeks
Change from baseline height at 12 weeks
Height was measured by height meter
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (20)
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.
Measured: 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.
Measured: 12 weeks
blood creatinine level in mg/dL
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
Measured: baseline
Change from baseline blood creatinine level at 12 weeks
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
blood HbA1c in percentage
The blood HbA1c in percentage as the insulin resistance index was measured by automated clinical chemistry analyzer.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start24 Mar 2017
- Primary completion23 Jan 2018
- Study completion23 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiun-Rong Chen, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035121
- Sponsor's protocol ID
- N201702034
- Status last verified
- Aug 2021
- First submitted
- 24 May 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05035121
- Acronym / sponsor ID
- N201702034
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, milk, soy milk, resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 24 Mar 2017 (actual)
- Primary completion
- 23 Jan 2018 (actual)
- Study completion
- 23 Mar 2018 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| milk supplement | Experimental | Dietary Supplement: milk supplement, Behavioral: resistance exerciseThe 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. |
| soy milk supplement | Experimental | Dietary Supplement: soy milk supplement, Behavioral: resistance exerciseThe 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. |
| control | Placebo comparator | Behavioral: resistance exerciseThe participants joined the resistance exercise training program, three times per week (30 min/time) during 12 weeks. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≧ 65 years old
- No allergies to milk and soy milk
- Sarcopenia cases (AWGS)
- Active ability
Key exclusion criteria (3 listed)
- End-of-life patient or estimated death within six months
- Last stage of cancer
- Chronic kidney disease stage 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| milk supplementIntervention 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) | Dietary supplement | milk supplement |
| soy milk supplementIntervention 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) | Dietary supplement | soy milk supplement |
| resistance exerciseThe participants joined the resistance exercise training program, three times per week (30 min/time) | Behavioural | control, milk supplement, soy milk supplement |
Primary outcome
appendicular skeletal muscle mass in kilograms
Time frame: baseline
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
Time frame: 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
Time frame: 12 weeks
The appendicular skeletal muscle mass was evaluated by bioelectrical impedance (BIA) analysis (Inbody S10, Inbody Inc., Seoul, South Korea)
height in meters
Time frame: baseline
Height was measured by height meter
Change baseline weeks height at 6 weeks
Time frame: 6 weeks
Height was measured by height meter
Change from baseline height at 12 weeks
Time frame: 12 weeks
Height was measured by height meter
appendicular skeletal muscle mass index in kg/m^2
Time frame: baseline
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
Time frame: 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
Time frame: 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
Time frame: baseline
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
Time frame: 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
Time frame: 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
Time frame: baseline
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
Time frame: 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
Time frame: 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
Time frame: baseline
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
Time frame: 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
Time frame: 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.
20 secondary outcomes
blood alanine transaminase activity in U/L
Time frame: baseline
Change from baseline blood alanine transaminase activity at 12 weeks
Time frame: 12 weeks
blood creatinine level in mg/dL
Time frame: baseline
Change from baseline blood creatinine level at 12 weeks
Time frame: 12 weeks
blood prealbumin level in mg/dL
Time frame: baseline
Change from baseline blood prealbumin level at 12 weeks
Time frame: 12 weeks
blood 25-hydroxyvitamin D level in ng/mL
Time frame: baseline
Change from baseline blood 25-hydroxyvitamin D level at 12 weeks
Time frame: 12 weeks
High sensitive C-reactive protein in mg/dL
Time frame: baseline
Change from baseline High sensitive C-reactive protein at 12 weeks
Time frame: 12 weeks
blood fasting blood sugar in mg/dL
Time frame: baseline
Change from baseline blood fasting blood sugar at 12 weeks
Time frame: 12 weeks
blood insulin level in milli-international unit/L
Time frame: baseline
Change from baseline blood insulin level at 12 weeks
Time frame: 12 weeks
blood HbA1c in percentage
Time frame: baseline
Change from baseline blood HbA1c at 12 weeks
Time frame: 12 weeks
Homeostasis model assessment-insulin resistance index (HOMA-IR)
Time frame: baseline
Change from baseline homeostasis model assessment-insulin resistance index (HOMA-IR) at 12 weeks
Time frame: 12 weeks
blood insulin-like growth factor 1 in mg/dL
Time frame: baseline
Change from baseline blood insulin-like growth factor 1 at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing milk supplement, soy milk supplement and resistance exercise in people with Sarcopenia, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appendicular skeletal muscle mass in kilograms (time frame: baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.