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Obesity is a major health issue worldwide; there is a constant raise in obesity related death each year. In vitro and animal studies elucidated Actiponin as a novel anti-obesity agent. However, the efficacy and safety of Actiponin supplementation on body weight regulation in humans are lacking.
The primary aim of the study was to investigate the effect of Actiponin in Korean subjects on body weight and fat loss along with changes in metabolic markers based on 12 week, randomized, double-blind, placebo-controlled clinical trial.
Eighty obesity subjects with BMI > 25kg/m2 and waist-hip ratio (WHR) ≥ 0.90 for men and ≥ 0.85 for women were randomly divided into either Actiponin (n=40, 450mg/day) or placebo group (n=40, 450mg/day) for 12weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actiponin | Experimental | Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks |
|
| Placebo | Placebo Comparator | Placebo(450mg/day) for 12weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actiponin | Dietary Supplement | The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Fat Mass. | Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week). | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Abdominal Total Fat Area. | Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week). | study visit 1(0 week), visit 4(12 week) |
| Changes in Body Weight. | Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Soo-Wan Chae, Ph.D, MD | Chonbuk National University Hospital | Study Chair |
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Among the 105 subjets screened, 25 subjects had anthropometric and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.
The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2009. Only those subjects who were obese[both BMI≥25kg/m2 and WHR≥0.90(men), WHR≥0.85(women)] and were not diagnosed with any disease were included in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Actiponin | Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material. |
| FG001 | Placebo | Placebo(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Actiponin | Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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), visit 2(4 week), visit 3(8 week) and visit 4(12 week). | Posted | Mean | Standard Error | kg | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) |
|
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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 | Actiponin | Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Soo-Wan Chae | Clinical Trial Center for Functional Food in Chonbuk National University Hospital | 82-63-250-2348 | soowan@jbnu.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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| ID | Term |
|---|---|
| C474918 | gypenoside |
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|
|
| Placebo | Dietary Supplement | Amount and calorie of placebo are same with Actiponin. |
|
|
| study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week) |
| Changes in Body Mss Index(BMI) | BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week). | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) |
| BG001 |
| Placebo |
Placebo(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Changes in Abdominal Total Fat Area. | Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week). | Posted | Mean | Standard Error | cm^2 | study visit 1(0 week), visit 4(12 week) |
|
|
|
|
| Secondary | Changes in Body Weight. | Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week). | Posted | Mean | Standard Error | kg | study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week) |
|
|
|
|
| Secondary | Changes in Body Mss Index(BMI) | BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week). | Posted | Mean | Standard Error | kg/m^2 | study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week) |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | Placebo(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin. | 0 | 0 | 0 | 0 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 8 week |
|
| 12 week |
|
| 8 week |
|
| 12 week |
|