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The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycin max(L.) Merr. pell extract | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycin max(L.) Merr. peel extract | Dietary Supplement | Glycin max(L.) Merr. peel extract (2.5g/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Fat Mass | Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Percent Body Fat | Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week). | 8 weeks |
| Changes in Weight | Weight was measured in study visit 1(0 week)and visit 3(8 week). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University | Seoul | 133-791 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycin Max(L.) Merr. Pell Extract | Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day) |
| FG001 | Placebo | Placebo: Placebo (2.5g/day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycin Max(L.) Merr. Pell Extract | Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day) |
| BG001 | Placebo | Placebo: Placebo (2.5g/day) |
| 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 | Changes in Body Fat Mass | Body Fat Mass was measured in study visit 1(0 week) and visit 3(8 week). | Posted | Mean | Standard Deviation | g | 8 weeks |
|
|
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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 | Glycin Max(L.) Merr. Pell Extract | Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yongsoon Park | Hanyang University | 82-2-2220-1205 | yongsoon@hanyang.ac.kr |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Placebo (2.5g/day) |
|
| 8 weeks |
| Changes in BMI(Body Mass Index) | BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week). | 8 weeks |
| Changes in LDLc | LDLc was measured in study visit 1(0week) and visit 3(8 week). | 8 weeks |
| Changes in Non-HDLc | Non-HDLc was measured in study visit 1(0week) and visit 3(8 week). | 8 weeks |
| Changes in LDLc/HDLc | LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week). | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Changes in Percent Body Fat | Percent Body Fat was measured in study visit 1(0 week) and visit 3(8 week). | Posted | Mean | Standard Deviation | percentage | 8 weeks |
|
|
|
| Secondary | Changes in Weight | Weight was measured in study visit 1(0 week)and visit 3(8 week). | Posted | Mean | Standard Deviation | kg | 8 weeks |
|
|
|
| Secondary | Changes in BMI(Body Mass Index) | BMI(body mass index) was measured in study visit 1(0week) and visit 3(8 week). | Posted | Mean | Standard Deviation | kg/m^2 | 8 weeks |
|
|
|
| Secondary | Changes in LDLc | LDLc was measured in study visit 1(0week) and visit 3(8 week). | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| Secondary | Changes in Non-HDLc | Non-HDLc was measured in study visit 1(0week) and visit 3(8 week). | Posted | Mean | Standard Deviation | mg/dl | 8 weeks |
|
|
|
| Secondary | Changes in LDLc/HDLc | LDLc/HDLc was measured in study visit 1(0week) and visit 3(8 week). | Posted | Mean | Standard Deviation | ratio | 8 weeks |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Placebo | Placebo: Placebo (2.5g/day) | 0 | 40 | 0 | 40 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |