ClinicalTrials.Veeva

Menu

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

C

China Medical University

Status

Completed

Conditions

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

Treatments

Dietary Supplement: multi-intervention program and protein foods supplementation

Study type

Interventional

Funder types

Other

Identifiers

NCT06173271
CMUH111-REC2-164

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

86 participants in 5 patient groups

Exercise only
Other group
Description:
Exercise only (60 min/times, 3 times/wk)
Treatment:
Dietary Supplement: multi-intervention program and protein foods supplementation
plant protein group
Active Comparator group
Description:
Soymilk (230ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)
Treatment:
Dietary Supplement: multi-intervention program and protein foods supplementation
animal protein group
Active Comparator group
Description:
Milk (240ml) and sweet potato (60g) supplementation after exercise (3 times/wk) plus nutrition education (once a wk)
Treatment:
Dietary Supplement: multi-intervention program and protein foods supplementation
Control
No Intervention group
Description:
No exercise and no nutrition education intervention
Exercise and Nutrition Education group
Active Comparator group
Description:
Exercise 60 min/times and three times per week Nutrition education 30 min/week
Treatment:
Dietary Supplement: multi-intervention program and protein foods supplementation

Trial contacts and locations

1

Loading...

Central trial contact

Yi-Chen Huang, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems