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| Name | Class |
|---|---|
| ITSWAY BIOTECH INC. | UNKNOWN |
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The aim of this study is to investigate the effects of I-Fiber Pearl on Body Weight and Body Fat in Obese Adults.
This randomized, double-blinded,placebo-controlled clinical trial will be conduct for 12 weeks with fifty adults. Subjects will be recruited and randomly assigned into two groups: (1) placebo, n = 25; (2) I-Fiber Pearl, n=25. During the 12 weeks intervention, the subjects should take 200g placebo or 200g I-Fiber Pearl a day . The two pearl are supplied in plastic packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, urine, feces and blood collection at week 0 and week 12.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo 200g, without any ingredients of inulin fiber. Eat 200g for once, and once a day. |
|
| I-Fiber Pearl | Experimental | I-Fiber Pearl 200g, with inulin fiber. Eat 200g for once, and once a day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-Fiber Pearl | Dietary Supplement | Eat 200g for once, and once a day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline body weight at week 12 | Compared the difference of body weight between the week 12 and 0. | Week 0, Week 12 |
| Change from baseline body fat at week 12 | Compared the difference of body fat between the week 12 and 0. | Week 0, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chin-Lin Hsu, Ph.D. | Chung Shan Medical University | Study Chair |
| Chin-Lin Hsu, Ph.D. | Chung Shan Medical University | Principal Investigator |
| Shiuan-Chih Chen, Dr. | Chung Shan Medical University | Principal Investigator |
| Hung-Hsuan Kuo, Master | Chung Shan Medical University | Principal Investigator |
| Chun-Tse Tsai, Master | Chung Shan Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung Shan Medical University | Taichung | South | 402 | Taiwan |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| placebo |
| Dietary Supplement |
Eat 200g for once, and once a day. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |