Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.

• ClinicalTrials.gov Identifier: NCT01667224
• Recruitment Status: Completed
• First Posted: August 17, 2012
• Results First Posted: April 21, 2014
• Last Update Posted: February 23, 2017
• Sponsor: Chonbuk National University Hospital
• Information provided by (Responsible Party): Soo-Wan Chae, Chonbuk National University Hospital

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Obesity
• Interventions: Dietary Supplement: Actiponin; Dietary Supplement: Placebo
• Enrollment: 80

Participant Flow

Recruitment Details	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.
Pre-assignment Details	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.

Arm/Group Title	Actiponin	Placebo
Arm/Group Description	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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
Period Title: Overall Study
Started	40	40
Completed	36	38
Not Completed	4	2
Reason Not Completed
Withdrawal by Subject	3	1
Protocol Violation	1	1

Baseline Characteristics

Arm/Group Title		Actiponin	Placebo	Total
Arm/Group Description		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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.	Total of all reporting groups
Overall Number of Baseline Participants		40	40	80
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	40 100.0%	40 100.0%	80 100.0%
	>=65 years	0 0.0%	0 0.0%	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	40 participants	40 participants	80 participants
		40.10 (9.67)	40.05 (11.58)	40.08 (10.60)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	40 participants	40 participants	80 participants
	Female	18 45.0%	30 75.0%	48 60.0%
	Male	22 55.0%	10 25.0%	32 40.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
Korea, Republic of	Number Analyzed	40 participants	40 participants	80 participants
		40	40	80

Outcome Measures

1. Primary Outcome

Title	Changes in Body Fat Mass.
Description	Body fat mass was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Time Frame	study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Actiponin	Placebo
Arm/Group Description:	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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
Overall Number of Participants Analyzed	40	40
Mean (Standard Error); Unit of Measure: kg
0 week	22.65 (3.12)	23.04 (3.55)
4 week	22.28 (3.45)	23.17 (3.61)
8 week	21.89 (3.35)	23.15 (3.8)
12 week	21.4 (3.62)	23.32 (3.82)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Actiponin, Placebo
	Comments	Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

2. Secondary Outcome

Title	Changes in Abdominal Total Fat Area.
Description	Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).
Time Frame	study visit 1(0 week), visit 4(12 week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Actiponin	Placebo
Arm/Group Description:	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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
Overall Number of Participants Analyzed	40	40
Mean (Standard Error); Unit of Measure: cm^2
Pre	332.24 (10.65)	335.36 (7.24)
Post	311.35 (9.04)	333.05 (8.36)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Actiponin, Placebo
	Comments	Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

3. Secondary Outcome

Title	Changes in Body Weight.
Description	Body weight was measured in study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week).
Time Frame	study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Actiponin	Placebo
Arm/Group Description:	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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
Overall Number of Participants Analyzed	40	40
Mean (Standard Error); Unit of Measure: kg
0 week	76.56 (8.31)	73.41 (9.79)
4 week	76.26 (8.35)	73.53 (9.79)
8 week	75.57 (8.18)	73.33 (9.98)
12 week	75.21 (8.2)	73.33 (10.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Actiponin, Placebo
	Comments	Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Data are present as the mean±S.D. to detect a 0.3kg(S.E.=0.6kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

4. Secondary Outcome

Title	Changes in Body Mss Index(BMI)
Description	BMI was measured in study visit 1 (0 week), visit 2 (4 week), visit 3 (8 week) and visit 4 (12 week).
Time Frame	study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Actiponin(450mg/Day) for 12week	Placebo (450mg/Day) for 12 Week
Arm/Group Description:	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: Amount and calorie of placebo are same with Actiponin
Overall Number of Participants Analyzed	40	40
Mean (Standard Error); Unit of Measure: kg/m^2
0 week	27.8 (1.21)	27.55 (1.27)
4 week	27.69 (1.17)	27.61 (1.36)
8 week	27.44 (1.28)	27.54 (1.45)
12 week	27.31 (1.24)	27.55 (1.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Actiponin(450mg/Day) for 12week, Placebo (450mg/Day) for 12 Week
	Comments	Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Data are present as the mean±S.E. to detect a 0.3kg(S.D.=0.60kg) difference in body weight between groups with 80% power and a two-tailed α-value of 0.05.
Statistical Test of Hypothesis	P-Value	<0.05
	Comments	[Not Specified]
	Method	Mixed Models Analysis
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Actiponin	Placebo
Arm/Group Description	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(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
All-Cause Mortality
	Actiponin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Actiponin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Actiponin	Placebo
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Soo-Wan Chae
• Organization: Clinical Trial Center for Functional Food in Chonbuk National University Hospital
• Phone: 82-63-250-2348
• EMail: soowan@jbnu.ac.kr

• Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital
• ClinicalTrials.gov Identifier: NCT01667224
• Other Study ID Numbers: TgBio-TG1022-001
• First Submitted: August 14, 2012
• First Posted: August 17, 2012
• Results First Submitted: March 16, 2014
• Results First Posted: April 21, 2014
• Last Update Posted: February 23, 2017