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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • 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
    • 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

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
Intervention / Treatment
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

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

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

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

China Medical University Hospital

Investigators

  • 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)

December 29, 2022

Primary Completion (Actual)

April 30, 2024

Study Completion (Actual)

April 30, 2024

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 15, 2023

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 6, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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