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The objective of this study are to evaluate efficacy and safety of protein product in volunteers with sarcopenia.
There are 45 patients in this study. They are randomly divided into 3 groups which are whey protein isolate group, isolated soy protein group, placebo group. They will take the sample 1 sachet/day for 12 weeks. Muscle strength, muscle mass, physical performance, sarcopenia score, body weight, body mass index, protein, immunoglobulins, quality of life, liver function, kidney function, other laboratory value, and adverse effects are evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whey protein isolate group | Experimental | Whey protein isolate is contained in the sachet. |
|
| isolated soy protein group | Experimental | Isolated soy protein, pea protein isolate, and brown rice protein are contained in the sachet. |
|
| placebo group | Experimental | Base powder without proteins is contained in the sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whey protein isolate | Dietary Supplement | Take 1 sachet/day for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Using handgrip strength instrument (high value means high strength) | 12 weeks |
| Muscle mass | Using Bioelectrical Impedance Analysis instrument (high value means high mass) | 12 weeks |
| Physical performance | Using Gait speed (6-meter walk) (low time period and low score of tired mean high physical performance. | 12 weeks |
| Sarcopenia score | Sarcopenia questionnaires (score 1 to 10 means low severity to high severity) | 12 weeks |
| Body weight | Body weight of the patients | 12 weeks |
| Body mass index | Body mass index of the patients | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional status | Nutritional score (score 0 to 17 means lack of nutrition, score 17 to 23.5 means risk to have lack of nutrition, score 24 to 30 means normal nutrition) | 12 weeks |
| Hungry feeling |
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Inclusion Criteria:
Exclusion Criteria:
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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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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| isolated soy protein |
| Dietary Supplement |
Take 1 sachet/day for 12 weeks. |
|
| placebo | Dietary Supplement | Take 1 sachet/day for 12 weeks. |
|
Using visual analogue scale 0 to 10 (No hungry to very hungry)
| 12 weeks |
| Quality of life of the patient | 36-Item Short Form Survey questionnaires shows in quality of life score 0 to 100 (High score means a better outcome) | 12 weeks |
| Concentration of total protein in serum | Measure concentration of total protein in serum | 12 weeks |
| Concentration of immunoglobulin in serum | Measure concentration of immunoglobulin in serum | 12 weeks |
| Concentration of glucose in serum | Measure concentration of glucose in serum | 12 weeks |
| Concentration of calcium in serum | Measure concentration of calcium in serum | 12 weeks |
| Concentration of magnesium in serum | Measure concentration of magnesium in serum | 12 weeks |
| Concentration of sodium in serum | Measure concentration of sodium in serum | 12 weeks |
| Concentration of creatinine in serum | Measure concentration of creatinine in serum | 12 weeks |
| Concentration of blood urea nitrogen in serum | Measure concentration of blood urea nitrogen in serum | 12 weeks |
| Concentration of aspartate transaminase in serum | Measure concentration of aspartate transaminase in serum | 12 weeks |
| Concentration of alanine aminotransferase in serum | Measure concentration of alanine aminotransferase in serum | 12 weeks |
| Concentration of alkaline phosphatase in serum | Measure concentration of alkaline phosphatase in serum | 12 weeks |
| Skin reaction | Found or not found | 12 weeks |
| Respiratory reaction | Found or not found | 12 weeks |
| Gastrointestinal tract reaction | Found or not found | 12 weeks |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |