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Sarcopenia is defined as a syndrome characterized by decline of skeletal muscle mass and strength or an alteration in physical function. Although some studies showed nutritional supplementation alone might have health benefits for older sarcopenic patients, the results were inconsistent and remain controversial. The objective of this study was to evaluate if a sufficient protein diet including supplements with leucine-enriched whey protein and vitamin D can lead to better improvement than sufficient dietary protein alone in maintaining muscle mass and strength among sarcopenic elders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supp group | Experimental | Each participant received nutritional counseling and recommended each of them to consume 1.5 g protein/kg body weight (BW)/day. Participants were encouraged to consume a balanced diet with six food groups follow "Daily dietary guideline of 2013 " as recommended by the Ministry of Health and Welfare of Taiwan. However, 1.2 g protein/kg body weight (BW)/day was suggested from this guideline. Subjects in the Supp group were provided with Protison with High Protein 51(Original Flavor) containing supplements in addition to their regular daily meals to achieve 1.5 g protein/kg (BW)/day on the basis of this guideline. |
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| Diet group | No Intervention | Each participant received nutritional counseling and recommended each of them to consume 1.5 g protein/kg body weight (BW)/day. Participants were encouraged to consume a balanced diet with six food groups follow "Daily dietary guideline of 2013 " as recommended by the Ministry of Health and Welfare of Taiwan. However, 1.2 g protein/kg body weight (BW)/day was suggested from this guideline. Subjects in the Diet group were instructed to consume ordinary high protein foods to achieve 1.5 g protein/kg body weight (BW)/day on the basis of this guideline, and suggested to equally distribute their meal time. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protison with High Protein 51(Original Flavor) | Dietary Supplement | Contents of each supplement sachet has a calorie of 88 kcal, 12.8 g protein( including 8.5 g whey protein concentrate), 1.2 g leucine, 7.3 g carbohydrates, 0.8 g fat and 120 IU vitamin D per serving. This supplement was added 200 ml water and stirred well, then drank before meal. |
| Measure | Description | Time Frame |
|---|---|---|
| AMMI(appendicular muscle mass index) | Bioelectrical impedance analysis was used to obtain appendicular muscle mass (AMM) and height. The unit of AMM and height were represented as kilogram and meter respectively. AMMI were calculated as AMM/height^2 (kg/m^2). | Change measures (baseline and 4 weeks, baseline and 12 weeks) |
| Handgrip strength | Hand dynamometer was used to measure handgrip strength. Subject was asked to sit in an upright position with the upper arm forming a virtually 90 degree angle with the forearm. Three consecutive measurements of grip strength obtained from both hands were recorded and average of the highest value was calculated as the maximum grip strength. The unit of handgrip strength was represented as kilogram. | Change measures (baseline and 4 weeks, baseline and 12 weeks) |
| Gait speed | Asking the subjects to perform a 5-meter walk at their usual pace and measure how much second they could complete this distance, then the unit of gait speed was represented as m/s. | Change measures (baseline and 4 weeks, baseline and 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Chien Lin | Family Medicine department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Far Eastern Memorial Hospital | New Taipei City | Banciao Dist | 220 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35177293 | Derived | Lin CC, Yeh SL. Reply to the letter to the editor: Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2022 Mar;41(3):792-793. doi: 10.1016/j.clnu.2022.01.030. Epub 2022 Feb 5. | |
| 32928579 | Derived |
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No plan to make individual participant data (IPD) available to other researchers.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| Lin CC, Shih MH, Chen CD, Yeh SL. Effects of adequate dietary protein with whey protein, leucine, and vitamin D supplementation on sarcopenia in older adults: An open-label, parallel-group study. Clin Nutr. 2021 Mar;40(3):1323-1329. doi: 10.1016/j.clnu.2020.08.017. Epub 2020 Aug 27. |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |