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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sarcopenia, Dietary Exposure, Nutrition, Healthy

Intervention / Treatment
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* Dietary Supplement: multi-intervention program and protein foods supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Exercise only (3 times/wk) | |
| Experimental: plant protein group<br>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<br>* 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.<br>|
| Experimental: animal protein group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, protein, exercise, nutritional education