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

NCT06173271 | Completed

• 1 other identifier: CMUH111-REC2-164
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sarcopenia; protein; exercise; nutritional education; bone health

Outcome Measures

Primary Outcomes (5)

• The effect of a multi-intervention program and exercise intervention on muscle mass

  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

  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

  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

  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

  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 Outcomes (1)

• 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

Other Outcomes (1)

• The effect of a multi-intervention program and exercise intervention on bone density

  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 Arms (5)

Exercise only

OTHER

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

Dietary Supplement: multi-intervention program and protein foods supplementation

plant protein group

ACTIVE COMPARATOR

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

animal protein group

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

No exercise and no nutrition education intervention

Exercise and Nutrition Education group

ACTIVE COMPARATOR

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

Dietary Supplement: multi-intervention program and protein foods supplementation

Interventions

multi-intervention program and protein foods supplementation 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.

Exercise and Nutrition Education group; Exercise only; animal protein group; plant protein group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Yi-Chen Huang

Taichung, Baseline and Post Test of Intervention, 406040, Taiwan

Location

Related Publications (1)

• Liao T, Wang TY, Lu MC, Kuo HL, Chen YL, Lin KC, Chen YL, Hsiao Y, Huang YC. Muscle performance and bone density following a multi-intervention program with milk or soy milk supplementation in older adults: quasi-experimental study. J Nutr Health Aging. 2026 Jan 22;30(3):100784. doi: 10.1016/j.jnha.2026.100784. Online ahead of print.

  PMID: 41576679 DERIVED

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Study Officials

• Yi-Chen Huang, PhD

  China Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: December 15, 2023
• Study Start: December 29, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

TW (1)