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The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days.
All subjects will be evaluated the body weight and clinical nutrition assessment such as postural measurement, urine test and blood biomarker examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Normal diet with 1500~2000 kcal |
|
| Treatment Group | Experimental | White sweet potato diet with 1500~2000 kcal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| White sweet potato diet | Dietary Supplement | The diet were supplied 516 kcal daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight After Intervention | Body weight change after 60 days intervention | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body Fat After Intervention | Body fat change after 60 days intervention | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chih-Han Lin, MS | Office of Human Research, Taipei Medical University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Normal diet White sweet potato meal replacement: The formula were supplied 516 kcal daily |
| FG001 | Treatment Group | Normal diet plus white sweet potato formula White sweet potato meal replacement: The formula were supplied 516 kcal daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Normal diet White sweet potato meal replacement: The formula were supplied 516 kcal daily |
| BG001 | Treatment Group | Normal diet plus white sweet potato formula White sweet potato meal replacement: The formula were supplied 516 kcal daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight After Intervention | Body weight change after 60 days intervention | Posted | Mean | Standard Deviation | Kg | 60 days |
|
|
The adverse event data were collected from the participants during intervention and assessed after 24 weeks.
No adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Normal diet White sweet potato meal replacement: The formula were supplied 516 kcal daily |
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Small sample size and trial duration that may cause impose an obstacle in the detection of significant changes of the study measure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sing-Chung Li | Taipei Medical University | 886-2-27361661 | 6560 | sinchung@tmu.edu.tw |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Participants |
|
|
| Secondary | Body Fat After Intervention | Body fat change after 60 days intervention | Posted | Mean | Standard Deviation | percentage of body fat | 60 days |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Treatment Group | Normal diet plus white sweet potato formula White sweet potato meal replacement: The formula were supplied 516 kcal daily | 0 | 29 | 0 | 29 | 0 | 29 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |