Trial Outcomes & Findings for Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects. (NCT NCT01667224)
NCT ID: NCT01667224
Last Updated: 2017-02-23
Results Overview
Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Results posted on
2017-02-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Placebo
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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.
|
Placebo
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
Baseline Characteristics
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
Baseline characteristics by cohort
| Measure |
Actiponin
n=40 Participants
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.
|
Placebo
n=40 Participants
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.10 years
STANDARD_DEVIATION 9.67 • n=5 Participants
|
40.05 years
STANDARD_DEVIATION 11.58 • n=7 Participants
|
40.08 years
STANDARD_DEVIATION 10.60 • n=5 Participants
|
|
Gender
Female
|
18 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Gender
Male
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Korea, Republic of
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Outcome measures
| Measure |
Actiponin
n=40 Participants
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.
|
Placebo
n=40 Participants
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Changes in Body Fat Mass.
0 week
|
22.65 kg
Standard Error 3.12
|
23.04 kg
Standard Error 3.55
|
|
Changes in Body Fat Mass.
4 week
|
22.28 kg
Standard Error 3.45
|
23.17 kg
Standard Error 3.61
|
|
Changes in Body Fat Mass.
8 week
|
21.89 kg
Standard Error 3.35
|
23.15 kg
Standard Error 3.8
|
|
Changes in Body Fat Mass.
12 week
|
21.4 kg
Standard Error 3.62
|
23.32 kg
Standard Error 3.82
|
SECONDARY outcome
Timeframe: study visit 1(0 week), visit 4(12 week)Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).
Outcome measures
| Measure |
Actiponin
n=40 Participants
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.
|
Placebo
n=40 Participants
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Changes in Abdominal Total Fat Area.
Pre
|
332.24 cm^2
Standard Error 10.65
|
335.36 cm^2
Standard Error 7.24
|
|
Changes in Abdominal Total Fat Area.
Post
|
311.35 cm^2
Standard Error 9.04
|
333.05 cm^2
Standard Error 8.36
|
SECONDARY outcome
Timeframe: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Outcome measures
| Measure |
Actiponin
n=40 Participants
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.
|
Placebo
n=40 Participants
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Changes in Body Weight.
0 week
|
76.56 kg
Standard Error 8.31
|
73.41 kg
Standard Error 9.79
|
|
Changes in Body Weight.
4 week
|
76.26 kg
Standard Error 8.35
|
73.53 kg
Standard Error 9.79
|
|
Changes in Body Weight.
8 week
|
75.57 kg
Standard Error 8.18
|
73.33 kg
Standard Error 9.98
|
|
Changes in Body Weight.
12 week
|
75.21 kg
Standard Error 8.2
|
73.33 kg
Standard Error 10.17
|
SECONDARY outcome
Timeframe: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).
Outcome measures
| Measure |
Actiponin
n=40 Participants
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.
|
Placebo
n=40 Participants
Placebo(450mg/day) for 12weeks
Placebo : Amount and calorie of placebo are same with Actiponin.
|
|---|---|---|
|
Changes in Body Mss Index(BMI)
12 week
|
27.31 kg/m^2
Standard Error 1.24
|
27.55 kg/m^2
Standard Error 1.54
|
|
Changes in Body Mss Index(BMI)
0 week
|
27.8 kg/m^2
Standard Error 1.21
|
27.55 kg/m^2
Standard Error 1.27
|
|
Changes in Body Mss Index(BMI)
4 week
|
27.69 kg/m^2
Standard Error 1.17
|
27.61 kg/m^2
Standard Error 1.36
|
|
Changes in Body Mss Index(BMI)
8 week
|
27.44 kg/m^2
Standard Error 1.28
|
27.54 kg/m^2
Standard Error 1.45
|
Adverse Events
Actiponin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Soo-Wan Chae
Clinical Trial Center for Functional Food in Chonbuk National University Hospital
Phone: 82-63-250-2348
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place