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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 immature ponkan (Citrus reticulate) extract on body weight and body fat in overweight and obese adults.
This randomized, placebo-controlled clinical trial will be conduct for 8 weeks with three hundred adults. Subjects will be recruited and randomly assigned into three groups: (1) placebo, n = 100; (2) immature ponkan extract, n=100; (3) immature ponkan extract with time restricted feeding, n=100. During the 8 weeks intervention, the subjects should take 25mL liquid of placebo or immature ponkan extract a day (drink 25mL for once, and once a day). The two drinks are supplied in aluminum foil packages, and both the products taste the same. Subjects also should complete the assessment of anthropometric measurement, intestinal questionnaire , food record, feces and blood collection at week 0, 4 and week 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | Placebo 25mL, without any ingredients of immature ponkan extract. Drink 25mL for once, and once a day. |
|
| immature ponkan (Citrus reticulate) extract | Experimental | Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day. |
|
| immature ponkan (Citrus reticulate) extract with time restricted feeding | Experimental | Immature ponkan (Citrus reticulate) extract 25 mL, drink 25mL for once, and once a day, adding time restricted feeding. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immature ponkan (Citrus reticulate) extract | Dietary Supplement | Drink 25mL for once, and once a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline body weight at week 8 | Compared the difference of body weight between the week 8 and 0. | Week 0, Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline body fat at week 8 | Compared the difference of body fat between the week 8 and 0. | Week 0, Week 8 |
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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-Ching Feng, 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 |
|---|---|
| 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 | Drink 25mL for once, and once a day. |
|
| time restricted feeding | Behavioral | Controlling a shortened period of time for eating within 8 hour each day. |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |