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| Name | Class |
|---|---|
| Laurel Corporation, Taiwan | UNKNOWN |
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The study is a 12-week randomized controlled trial designed to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults. Participants are randomly assigned to either an intervention group, which is provided one commercial soup (24-30g of protein) per day for 12 weeks, or the control group, which does not receive this supplement. The investigators also assess the frail status, Mini-Mental Status Examination, Geriatric Depression Scale, Mini Nutritional Assessment, WHOQOL-BREF, and blood tests as outcome measures.
As age increases, the muscle mass of the individual will gradually decrease, which will affect muscle strength and function. If the condition continues to deteriorate, the individual may develop a syndrome of "sarcopenia" in the elderly. In addition to age, risk factors related to sarcopenia include living alone, excessive drinking, lack of physical activity, malnutrition, and oral and dental problems. Among them, lack of physical activity and malnutrition are considered potential risk factors for preventing or improving sarcopenia. Sufficient protein intake is an important method for frail elderly people to improve malnutrition and further prevent or reverse sarcopenia. There were few studies in the past. Some studies had enrolled older adults with sarcopenia, but the participants did not necessarily have nutritional risks; other studies had enrolled individuals with nutritional risks but without complete evaluation for sarcopenia (especially muscle mass). In addition, the components of nutritional supplements should also be adjusted in response to different dietary preferences. For example, past studies have rarely provided protein-enriched nutritional supplements that can be used by Lacto-vegetarian. Therefore, this study aims to evaluate the clinical effects of protein-enriched Lacto-vegetarian soups on body composition, muscle strength, and physical performance among community-dwelling older adults with risk of sarcopenia and malnutrition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in the control group will not receive any intervention during the study period. | |
| Protein nutritional supplement group | Experimental | Participants in the intervention group will receive protein-enriched soups (24-30g of protein) per day for 12 weeks. Protein may come from either soy, bean or milk products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protein nutritional supplement | Dietary Supplement | Participants in the intervention group will receive protein-enriched soups (24-30g of protein). Protein may come from either soy, bean or milk products. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline muscle strength measure by hand grip strength after 12 weeks | measured by hand grip strength | baseline, 12 weeks |
| Change from baseline walking speed after 12 weeks | measured by six-meter walking speed | baseline, 12 weeks |
| Changes from baseline physical performance after 12 weeks | measured by Short Physical Performance Battery | baseline, 12 weeks |
| Changes from baseline frailty after 12 weeks | measured by Clinical Frailty Scale | baseline, 12 weeks |
| Changes from baseline frail status after 12 weeks | measured by Fatigue, Resistance, Ambulation, Illnesses, & Loss of Weight scale | baseline, 12 weeks |
| Changes from baseline cognition after 12 weeks | measured by Mini-Mental Status Examination | baseline, 12 weeks |
| Changes from baseline depression after 12 weeks | measured by Geriatric Depression Scale | baseline, 12 weeks |
| Changes from baseline quality of life after 12 weeks | measured by WHOQOL-BREF (Taiwan Version) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline complete blood count 12 weeks | Change from baseline complete blood count 12 weeks | baseline, 12 weeks |
| Change from baseline differential count 12 weeks | Change from baseline differential count 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ching-Hui Loh, MD.PhD. | Buddhist Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi General Hospital | Hualien City | 97071 | Taiwan |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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This program is designed as a parallel randomized intervention. The primary purpose of this program is Prevention.
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| baseline, 12 weeks |
| Changes from baseline physical activity after 12 weeks | measured by the International Physical Activity Questionnaire (IPAQ) | baseline, 12 weeks |
| Changes from baseline nutritional status after 12 weeks | measured by Mini-Nutritional Assessment-Short Form (MNA-SF) | baseline, 12 weeks |
| Changes from baseline dietary assessment after 12 weeks | measured by Food Frequency Questionnaires (FFQ) | baseline, 12 weeks |
| baseline, 12 weeks |
| Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks | Change from baseline percentage of glycated hemoglobin (HbA1c) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks | Change from baseline concentration of alanine aminotransferase (ALT) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks | Change from baseline concentration of aspartate aminotransferase (AST) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks | Change from baseline concentration of blood urea nitrogen (BUN) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of Creatinine after 12 weeks | Change from baseline concentration of Creatinine after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of sodium after 12 weeks | Change from baseline concentration of sodium after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of potassium after 12 weeks | Change from baseline concentration of potassium after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of uric acid after 12 weeks | Change from baseline concentration of uric acid after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of total protein after 12 weeks | Change from baseline concentration of total protein after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of albumin after 12 weeks | Change from baseline concentration of albumin after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of globulin after 12 weeks | Change from baseline concentration of globulin after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of cholesterol after 12 weeks | Change from baseline concentration of cholesterol after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks | Change from baseline concentration of high-density lipoprotein cholesterol (HDL-C) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks | Change from baseline concentration of low-density lipoprotein cholesterol (LDL-C) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of triglyceride after 12 weeks | Change from baseline concentration of triglyceride after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of fasting glucose after 12 weeks | Change from baseline concentration of fasting glucose after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks | Change from baseline concentration of high-sensitivity C-reactive protein (hs-CRP) after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of fasting insulin after 12 weeks | Change from baseline concentration of fasting insulin after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of Vitamin D after 12 weeks | Change from baseline concentration of Vitamin D after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of Vitamin B12 after 12 weeks | Change from baseline concentration of Vitamin B12 after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of homocysteine after 12 weeks | Change from baseline concentration of homocysteine after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of cystatin C after 12 weeks | Change from baseline concentration of cystatin C after 12 weeks | baseline, 12 weeks |
| Change from baseline concentration of DHEA-S after 12 weeks | Change from baseline concentration of DHEA-S after 12 weeks | baseline, 12 weeks |
| Change from baseline body weight after 12 weeks | Change from baseline body weight after 12 weeks | baseline, 12 weeks |
| Change from baseline fat mass after 12 weeks | Change from baseline fat mass after 12 weeks | baseline, 12 weeks |
| Change from baseline muscle mass after 12 weeks | Change from baseline muscle mass after 12 weeks | baseline, 12 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |