The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia

October 6, 2024 updated by: China Medical University Hospital
Sarcopenia is characterized by loss of skeletal muscle mass and strength with advancing age. It is linked to an increased risk of falls, disability, length of hospitalization, poor quality of life, and burden of health care. Nutrition and physical activity are the major modifiable factors to prevent and mitigate sarcopenia. However, most studies focused on the explore the effects of physical activity or single nutrient supplementation. Whether a multi-intervention program combining protein-rich food intake, nutrition education, and exercise can more effectively reduce the risk of sarcopenia still needs to be explored at the community level. This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia. The primary outcome is to evaluate the effect of a multi-intervention program and exercise intervention only. The second outcome is to assess the impact of animal and plant source protein on muscle mass and physical performance. Investigators will recruit the study participants over the age of 60 from the free-living community. All participants were randomized into five groups: animal protein, plant protein, exercise and nutrition education, exercise alone, and control. For 8 weeks, except for control group, all four groups receive resistance training 3 times/week. However, the animal and plant protein groups provide milk 240 mL and soy milk 230 mL (7-8 g protein/serving) after exercise, respectively, and receive personal nutritional counseling and education to adhere to dietary recommendations. Dual-energy X-Ray using to evaluate the body composition and measure the grip strength, five-time chair stand test, and gait speed to assess physical performance pre- and post-intervention. The results of this study can be used to prevent muscle mass loss and frailty for older adults in the community.

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.

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.
86

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
    • Baseline And Post Test Of Intervention
      • Taichung, Baseline And Post Test Of Intervention, Taiwan, 406040
        • Yi-Chen Huang

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • over the age of 60 from the free-living community

Exclusion Criteria:

  • Kidney patients, diabetics, cancer patients, moderate/severe cognitively impaired, disability, those who take any commercial protein nutritional supplements, those who are underweight, vegans, food allergy to dairy products and soy products

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: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

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.
Other: Exercise only
Exercise only (60 min/times, 3 times/wk)
Dietary supplement: multi-intervention program and protein foods supplementation
This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia.
Active Comparator: plant protein group
Soymilk (230ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)
Dietary supplement: multi-intervention program and protein foods supplementation
This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia.
Active Comparator: animal protein group
Milk (240ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)
Dietary supplement: multi-intervention program and protein foods supplementation
This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia.
No Intervention: Control
No exercise and no nutrition education intervention
Active Comparator: Exercise and Nutrition Education group
Exercise 60 min/times and three times per week Nutrition education 30 min/week
Dietary supplement: multi-intervention program and protein foods supplementation
This study aimed to investigate the effects of a multi-intervention program (protein-rich food supplement, nutrition education, and exercise) on reducing the risk of sarcopenia.

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
The effect of a multi-intervention program and exercise intervention on muscle mass
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in muscle mass will be assessed by DXA in kilogram/meter2.
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on calf circumference
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in calf circumference will be assessed by tape in cm
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on grip strength
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in grip strength will be assessed by grip meter in kg
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on walking speed
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in walking speed will be assessed by timer in meters/second
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The effect of a multi-intervention program and exercise intervention on sit-to-stand speed
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in sit-to-stand test will be assessed by timer in second
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 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
The effect of a multi-intervention program and exercise intervention on dietary intake
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in dietary intake at 8 weeks will be assessed by questionnaire.
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 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
The effect of a multi-intervention program and exercise intervention on bone density
Time Frame: From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 12 weeks
The changes from baseline in bone density will be assessed by DXA in T-score.
From the date of the first time to collect the baseline data until the date of completion of the study (after intervention), assessed up to 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.
China Medical University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi-Chen Huang, PhD, China Medical University, China

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.
December 29, 2022

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.
April 30, 2024

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.
April 30, 2024

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).
February 7, 2023

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.
December 13, 2023

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.
December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
October 9, 2024

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.
October 6, 2024

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.
October 1, 2024

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.
  • CMUH111-REC2-164

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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