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Completed

NCT Number: NCT06173271

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yi-Chen Huang

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. The effect of a multi-intervention program and exercise intervention on dietary intake

    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 dietary intake at 8 weeks will be assessed by questionnaire.

Other outcomes

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

    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 bone density will be assessed by DXA in T-score.

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 15, 2023
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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