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Clinical Trials/NCT06173271
NCT06173271
Completed
N/A

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

China Medical University Hospital1 site in 1 country86 target enrollmentDecember 29, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sarcopenia
Sponsor
China Medical University Hospital
Enrollment
86
Locations
1
Primary Endpoint
The effect of a multi-intervention program and exercise intervention on walking speed
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 29, 2022
End Date
April 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

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.

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

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

Secondary Outcomes

  • The effect of a multi-intervention program and exercise intervention on dietary intake(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)

Study Sites (1)

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