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This project will mainly focus on Middle and old-aged adults, and examine whether Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will develop strategies for improving muscle loss , muscle strength decline, and the quality life of the elderly.
Cardiovascular diseases are common among the elder. However, previous researches mainly focus on observational research or small scale clinical trial, and the subjects are mainly youth. Therefore, this project hope to understand whether Oligonol can reduce Cardiovascular and metabolic risks among senior adults. Consequently,improve muscle loss muscle strength decline, quality of old adults life. This project design may potentially develop new strategies for curing Sarcopenia as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oligonol intake group | Experimental | This experimental arm will be applied for Oligonol 200mg/tab 1 tab per day. The program will last for 12 weeks. |
|
| Placebo group | Placebo Comparator | This Placebo arm will be given capsules made of starch 1 tab per day. The program will last for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oligonol intake | Dietary Supplement | Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline muscle after 12 weeks | Change from baseline muscle via MRI after 12 weeks. | baseline,12 weeks |
| Changes from baseline fat content of leg after 12 weeks | Change from baseline fat content of leg via MRI after 12 weeks. | baseline,12 weeks |
| Changes form baseline chair-stand after 12 weeks | measured by the time of chair-stand after 12 weeks. | baseline, 12 weeks |
| Changes form baseline muscle strength after 12 weeks | measured by hand grip distance after 12 weeks. | baseline, 12 weeks |
| Change from baseline Nutrition intake after 12 weeks | measured by Mini-nutritional assessment questionnaire. ranged 0-30, higher values represent a better condition | baseline, 12 weeks |
| Change from baseline depression after 12 weeks | measured by the Center for Epidemiological Studies-Depression (CES-D) ranged 0-60, higher values represent a worse condition | baseline, 12 weeks |
| Change from baseline endurance after 12 weeks | measured by 6-minute walk distance | baseline, 12 weeks |
| Change from baseline walking speed after 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline numbers of Complete blood count after 12 weeks | Change from baseline numbers of Complete blood count after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of Albumin after 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang-Kung Chen, MD.PhD. | Center for Healthy Longevity and Aging Sciences, National Yang Ming University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veteran General Hospital | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
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| Placebo | Dietary Supplement | Placebo |
|
measured by six-meter walking speed |
| baseline, 12 weeks |
| Change from baseline timed up and go test after 12 weeks | measured by timed up and go test (TUG) | baseline, 12 weeks |
Change from baseline concentration of Albumin 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 after 12 weeks | Change from baseline concentration of blood urea nitrogen after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of Creatinin after 12 weeks | Change from baseline concentration of Creatinin 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 Total Cholesterol after 12 weeks | Change from baseline concentration of Total Cholesterol 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 high-density lipoprotein cholesterol after 12 weeks | Change from baseline concentration of high-density lipoprotein cholesterol after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks | Change from baseline concentration of low-density lipoprotein cholesterol after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks | Change from baseline concentration of high-sensitivity C-reactive protein after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of dehydroepiandrosterone after 12 weeks | Change from baseline concentration of dehydroepiandrosterone after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks | Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of Leptin after 12 weeks | Change from baseline concentration of 25-(OH)-Vit. D after 12 weeks | baseline,12 weeks |
| Change from baseline concentration of urine protein after 12 weeks | Change from baseline concentration of urine protein after 12 weeks | baseline,12 weeks |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010335 | Pathologic Processes |