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| Name | Class |
|---|---|
| TCI Co., Ltd. | INDUSTRY |
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The aim of this study is to investigate the effects of probiotics product (probiotics fruit vegetable fiber powder) on intestinal health and immune system improvement in adults
This 12 weeks randomized, single-blind and placebo-controlled study will be conduct in fifty adults. Subjects will be recruited and assigned into two groups in a 1:1 ratio (placebo, n = 25; probiotics, n=25). During the 12 weeks intervention, the subjects should take 32 g powder of placebo or probiotics product (eat 16 g for once, and twice a day). The two powder supplied in an aluminum sachet, and all products were identical in taste. Subjects also should complete the assessment of anthropometric measurement, health conditions, food record, and sample collection (feces and blood) at week 0, 4, 8 and week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Experimental | 32g probiotics fruit vegetable fiber powder product contained 1.12*10(11) CFU of probiotics for 12 weeks |
|
| Placebo | Placebo Comparator | 32g placebo contained only maltodextrin (100%) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotics fruit vegetable fiber powder product | Dietary Supplement | Eat 16 g for once, and twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline serum TNF-α at week 12 | Compared the difference of serum cytokine TNF-α level between the week 12 and 0 | Week0, Week12 |
| Change from baseline serum IL-6 at week 12 | Compared the difference of serum IL-6 level between the week 12 and 0 | Week0, Week12 |
| Change from baseline serum IL-10 at week 12 | Compared the difference of serum IL-10 level between the week 12 and 0 | Week0, Week12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chin-Lin Hsu, Professor | Contact | 04-24730022 | 12222 | clhsu@csmu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Yu-Jou Chien, PhD Student | Chung Shan Medical University | Principal Investigator |
| Ying-Chi Chen, MS Student | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Recruiting | Taichung | South | 402 | Taiwan |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | Eat 16 g for once, and twice a day |
|
| D019602 |
| Food and Beverages |