FindTrial
Sign In

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

Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01667224
Enrollment
80
Registered
2012-08-17
Start date
2009-10-31
Completion date
2010-10-31
Last updated
2017-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Actiponin, Obesity, Abdominal fat

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTActiponin

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.

DIETARY_SUPPLEMENTPlacebo

Amount and calorie of placebo are same with Actiponin.

Sponsors

Chonbuk National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)

Exclusion criteria

* Significant variation in weight(more 10%) in the past 3 months * Cardiovascular disease, e.g. arrhythmia, heart failure, myocardial infarction, and patient with pacemaker * History of disease that could interfere with the test products or impede theire absorption, such as gastrointestinal disease or gastrointestinal surgery * Participation in any other clinical trials within past 2 months * Abdominal hepatic liver function * Renal disease, e.g. acute/chronic renal failure, nephritic syndrome * Used antipsychosis drugs therapy within past 2 months * Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study * Pregnancy or breast feeding * History of alcohol or substance abuse * Allergic or hypersensitive to any of the ingredients in the test products

Design outcomes

Primary

MeasureTime frameDescription
Changes in Body Fat Mass.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).

Secondary

MeasureTime frameDescription
Changes in Abdominal Total Fat Area.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).
Changes in Body Weight.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).
Changes in Body Mss Index(BMI)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).

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.

Participants by arm

ArmCount
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.
40
Placebo
Placebo(450mg/day) for 12weeks Placebo : Amount and calorie of placebo are same with Actiponin.
40
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation11
Overall StudyWithdrawal by Subject31

Baseline characteristics

CharacteristicPlaceboActiponinTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
40 Participants40 Participants80 Participants
Age, Continuous40.05 years
STANDARD_DEVIATION 11.58
40.10 years
STANDARD_DEVIATION 9.67
40.08 years
STANDARD_DEVIATION 10.6
Gender
Female
30 Participants18 Participants48 Participants
Gender
Male
10 Participants22 Participants32 Participants
Region of Enrollment
Korea, Republic of
40 participants40 participants80 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

ArmMeasureGroupValue (MEAN)Dispersion
ActiponinChanges in Body Fat Mass.0 week22.65 kgStandard Error 3.12
ActiponinChanges in Body Fat Mass.4 week22.28 kgStandard Error 3.45
ActiponinChanges in Body Fat Mass.8 week21.89 kgStandard Error 3.35
ActiponinChanges in Body Fat Mass.12 week21.4 kgStandard Error 3.62
PlaceboChanges in Body Fat Mass.12 week23.32 kgStandard Error 3.82
PlaceboChanges in Body Fat Mass.0 week23.04 kgStandard Error 3.55
PlaceboChanges in Body Fat Mass.8 week23.15 kgStandard Error 3.8
PlaceboChanges in Body Fat Mass.4 week23.17 kgStandard Error 3.61
Comparison: 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.p-value: <0.05Mixed Models Analysis
Secondary

Changes in Abdominal Total Fat Area.

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)

ArmMeasureGroupValue (MEAN)Dispersion
ActiponinChanges in Abdominal Total Fat Area.Pre332.24 cm^2Standard Error 10.65
ActiponinChanges in Abdominal Total Fat Area.Post311.35 cm^2Standard Error 9.04
PlaceboChanges in Abdominal Total Fat Area.Pre335.36 cm^2Standard Error 7.24
PlaceboChanges in Abdominal Total Fat Area.Post333.05 cm^2Standard Error 8.36
Comparison: 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.p-value: <0.05Mixed Models Analysis
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).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)

ArmMeasureGroupValue (MEAN)Dispersion
ActiponinChanges in Body Mss Index(BMI)0 week27.8 kg/m^2Standard Error 1.21
ActiponinChanges in Body Mss Index(BMI)4 week27.69 kg/m^2Standard Error 1.17
ActiponinChanges in Body Mss Index(BMI)8 week27.44 kg/m^2Standard Error 1.28
ActiponinChanges in Body Mss Index(BMI)12 week27.31 kg/m^2Standard Error 1.24
PlaceboChanges in Body Mss Index(BMI)12 week27.55 kg/m^2Standard Error 1.54
PlaceboChanges in Body Mss Index(BMI)0 week27.55 kg/m^2Standard Error 1.27
PlaceboChanges in Body Mss Index(BMI)8 week27.54 kg/m^2Standard Error 1.45
PlaceboChanges in Body Mss Index(BMI)4 week27.61 kg/m^2Standard Error 1.36
Comparison: 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.p-value: <0.05Mixed Models Analysis
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).

Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)

ArmMeasureGroupValue (MEAN)Dispersion
ActiponinChanges in Body Weight.4 week76.26 kgStandard Error 8.35
ActiponinChanges in Body Weight.12 week75.21 kgStandard Error 8.2
ActiponinChanges in Body Weight.8 week75.57 kgStandard Error 8.18
ActiponinChanges in Body Weight.0 week76.56 kgStandard Error 8.31
PlaceboChanges in Body Weight.12 week73.33 kgStandard Error 10.17
PlaceboChanges in Body Weight.0 week73.41 kgStandard Error 9.79
PlaceboChanges in Body Weight.8 week73.33 kgStandard Error 9.98
PlaceboChanges in Body Weight.4 week73.53 kgStandard Error 9.79
Comparison: 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.p-value: <0.05Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026