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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173271
• Other study ID #: CMUH111-REC2-164
• Status: Recruiting
• Phase: N/A
• Start date: December 29, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: China Medical University Hospital
• Contact: Yi-Chen Huang, PhD
• Phone: 886-4-22053366
• Email: yichenhuang[@]mail.cmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 three groups: animal protein, plant protein, and control group. For 8 weeks, all three 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dietary Exposure
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Yi-Chen Huang	Taichung	Baseline And Post Test Of Intervention

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The effect of a multi-intervention program and exercise intervention on bone density	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	The effect of a multi-intervention program and exercise intervention on dietary intake	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