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This study aims to conduct a 24-week intervention involving formula milk powder for middle-aged and elderly individuals, assessing its impact on body composition and physical performance in comparison to interventions using regular milk powder and individuals without intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fortified formula milk powder group | Experimental | Fortified formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. |
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| formula milk powder group | Experimental | Formula milk powder is supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate, and packaged in 25-gram sachets. The milk powder is consumed orally, two sachets per day, for a duration of 24 weeks. |
|
| regular milk powder group | Placebo Comparator | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
|
| observation group | No Intervention | Participants in the observation group did not receive any supplementation. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fortified formula milk powder | Dietary Supplement | Fortified formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, β-hydroxy-β-methylbutyrate, and sodium hyaluronate per day orally for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| lean body mass | At baseline, and 24 weeks, investigators will use DXA to examine lean body mass and fat composition. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| cardiorespiratory fitness | At baseline, and 24 weeks, investigators will use cardiopulmonary exercise testing (CPET) on a cycle ergometer to evaluate cardiorespiratory fitness. | up to 24 weeks |
| muscle strength |
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Inclusion Criteria:
Exclusion Criteria:
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| formula milk powder | Dietary Supplement | Formula milk powder supplemented with whey protein, calcium, vitamin D, colostrum basic protein, and sodium hyaluronate per day orally for 24 weeks. |
|
| regular milk powder | Dietary Supplement | Regular milk powder does not contain and additional supplementation, and the color, flavor, shape, taste, and weight are same with the formula milk powder. |
|
At baseline, 12, and 24 weeks, investigators will test hand grip to assess muscle strength.
| up to 24 weeks |
| physical performance | At baseline, 12, and 24 weeks, investigators will test the Short Physical Performance Battery (SPPB) to assess muscular function. | up to 24 weeks |
| the levels of blood metabolic markers for bone and muscle | At baseline, and 24 weeks, blood samples will be drawn and serum indexes of bone and muscle metabolism will be test, including myostatin, PINP, CTx, and osteocalcin. | up to 24 weeks |