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

August 31, 2021 updated by: Jiun-Rong Chen, Taipei Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
baseline
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)
6 weeks
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)
12 weeks
height in meters
Time Frame: baseline
Height was measured by height meter
baseline
Change baseline weeks height at 6 weeks
Time Frame: 6 weeks
Height was measured by height meter
6 weeks
Change from baseline height at 12 weeks
Time Frame: 12 weeks
Height was measured by height meter
12 weeks
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.
baseline
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.
6 weeks
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.
12 weeks
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.
baseline
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.
6 weeks
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.
12 weeks
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)
baseline
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)
6 weeks
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)
12 weeks
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.
baseline
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.
6 weeks
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.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
blood alanine transaminase activity in U/L
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
baseline
Change from baseline blood creatinine level at 12 weeks
Time Frame: 12 weeks
The blood creatinine level was measured as kidney function by automated clinical chemistry analyzer.
12 weeks
blood prealbumin level in mg/dL
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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)
Time Frame: baseline
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
Time Frame: 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
Time Frame: baseline
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
Time Frame: 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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
diet assessment
Time Frame: baseline
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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 24, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 23, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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