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This study evaluates the effects of a 12-week leucine-enriched protein supplementation in adults aged 60 years and more. Participants will undergo assessments of muscle mass and function, as well as metabolic profiles in blood, urine, and feces before and after the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Protein Supplementation Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants consume two sachets daily over a 12-week intervention period. | Dietary Supplement | Each 8 g serving provided 35 kcal, comprising 4.1 g of protein, 1 g of fat, and 2.4 g of carbohydrates. |
| Measure | Description | Time Frame |
|---|---|---|
| Appendicular Skeletal Muscle Index (ASMI) | Muscle mass was assessed using bioelectrical impedance analysis (Tanita MC-780MA). The appendicular skeletal muscle index (ASMI, kg/m2) was calculated as appendicular skeletal muscle mass (ASM, kg) divided by height squared (m²). | Baseline and 12 weeks after intervention |
| Handgrip Strength (HGS) | Functional performance was evaluated by handgrip strength (HGS, kg), measured with a digital hand dynamometer. | Baseline and 12 weeks after intervention |
| Gait speed (m/s) | Gait speed was assessed as the time required to walk a 4 meters, expressed in meters per second (m/s). | Baseline and 12 weeks after intervention |
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Inclusion Criteria:
Grip strength: Men < 28 kg; Women < 18 kg Gait speed: < 1.0 m/s Muscle mass (appendicular skeletal muscle mass / height²): Men < 7.0 kg/m²; Women < 5.7 kg/m²
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Guishan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36081299 | Background | Prado CM, Landi F, Chew STH, Atherton PJ, Molinger J, Ruck T, Gonzalez MC. Advances in muscle health and nutrition: A toolkit for healthcare professionals. Clin Nutr. 2022 Oct;41(10):2244-2263. doi: 10.1016/j.clnu.2022.07.041. Epub 2022 Aug 7. | |
| 35777246 | Background | Lee SY, Lee HJ, Lim JY. Effects of leucine-rich protein supplements in older adults with sarcopenia: A systematic review and meta-analysis of randomized controlled trials. Arch Gerontol Geriatr. 2022 Sep-Oct;102:104758. doi: 10.1016/j.archger.2022.104758. Epub 2022 Jun 24. |
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Due to ethical and privacy considerations, individual participant data will not be publicly available. De-identified data may be shared upon reasonable request and with approval from the institutional review board.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2022 | Dec 8, 2025 | Prot_SAP_000.pdf |
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