Clinical trial NCT06173271: The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia
Official title: The Effect of a Multi-intervention Program and Protein Food Sources on Preventing and Mitigating Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Dietary Exposure
Nutrition, Healthy
Bone Health
Muscle Function
Muscle Performance
Keywords: sarcopenia
protein
exercise
nutritional education
bone health
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 86
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: The effect of a multi-intervention program and exercise intervention on muscle mass
timeFrame: 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
measure: The effect of a multi-intervention program and exercise intervention on calf circumference
timeFrame: 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
measure: The effect of a multi-intervention program and exercise intervention on grip strength
timeFrame: 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
measure: The effect of a multi-intervention program and exercise intervention on walking speed
timeFrame: 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
measure: The effect of a multi-intervention program and exercise intervention on sit-to-stand speed
timeFrame: 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:
measure: The effect of a multi-intervention program and exercise intervention on dietary intake
timeFrame: 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:
measure: The effect of a multi-intervention program and exercise intervention on bone density
timeFrame: 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
Locations:
city: Taichung
country: Taiwan
facility: Yi-Chen Huang
state: Baseline And Post Test Of Intervention
Study officials:
affiliation: China Medical University, China
name: Yi-Chen Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: