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

NCT ID: NCT06173271

Last Updated: 2024-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-29

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sarcopenia Dietary Exposure Nutrition, Healthy Bone Health Muscle Function Muscle Performance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise only

Exercise only (60 min/times, 3 times/wk)

Group Type OTHER

multi-intervention program and protein foods supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

plant protein group

Soymilk (230ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)

Group Type ACTIVE_COMPARATOR

multi-intervention program and protein foods supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

animal protein group

Milk (240ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)

Group Type ACTIVE_COMPARATOR

multi-intervention program and protein foods supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

Control

No exercise and no nutrition education intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise and Nutrition Education group

Exercise 60 min/times and three times per week Nutrition education 30 min/week

Group Type ACTIVE_COMPARATOR

multi-intervention program and protein foods supplementation

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China Medical University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi-Chen Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

China Medical University, China

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yi-Chen Huang

Taichung, Baseline and Post Test of Intervention, Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CMUH111-REC2-164

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition and Exercise for Sarcopenia
NCT00872911 COMPLETED PHASE1