ObesityPhase 2NCT01667224
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
A Phase 2 study testing Actiponin in people with Obesity, run by Chonbuk National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Actiponin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)
Who cannot join
- 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
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- 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
About this study
Official title: Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Actiponin, Placebo
- Keywords
- Actiponin, Obesity, Abdominal fat
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiponinDietary supplement
Also called Extract of Gynostemma pentaphyllum(450mg/day)
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.
PlaceboDietary supplement
Also called Placebo(450mg/day)
Amount and calorie of placebo are same with Actiponin.
| Study group | Role | What they receive |
|---|---|---|
| Actiponin | Experimental | Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks Receives: Dietary Supplement: Actiponin |
| Placebo | Placebo comparator | Placebo(450mg/day) for 12weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Secondary outcomes (3)
Changes in Abdominal Total Fat Area.
Abdominal total fat area was measured in study visit 1(0 week) and visit 4(12 week).
Measured: 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).
Measured: 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).
Measured: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startOct 2009
- Primary completionAug 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo-Wan Chae, Chonbuk National University Hospital
- Investigators
- Soo-Wan Chae, Ph.D, MD, Study chair, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667224
- Sponsor's protocol ID
- TgBio-TG1022-001
- Status last verified
- Jan 2017
- First submitted
- 14 Aug 2012
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actiponin Supplementation Reduces Abdominal Fat Area, Weight, Body Fat Mass and BMI in Obese Korean Subjects.
- ClinicalTrials.gov ID
- NCT01667224
- Acronym / sponsor ID
- TgBio-TG1022-001
- Conditions
- Obesity
- Keywords
- Actiponin, Obesity, Abdominal fat
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actiponin | Experimental | Dietary Supplement: ActiponinActiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo(450mg/day) for 12weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI ≥ 25kg/m2 and WHR ≥ 0.90(men), WHR ≥ 0.85(women)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiponinAlso: Extract of Gynostemma pentaphyllum(450mg/day)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 supplement | Actiponin |
| PlaceboAlso: Placebo(450mg/day)Amount and calorie of placebo are same with Actiponin. | Dietary supplement | Placebo |
Primary outcome
Changes in Body Fat Mass.
Time frame: 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).
3 secondary outcomes
Changes in Abdominal Total Fat Area.
Time frame: study visit 1(0 week), visit 4(12 week)
Changes in Body Weight.
Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week), and visit 4(12 week)
Changes in Body Mss Index(BMI)
Time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soo-Wan Chae, Ph.D, MD study chair
Chonbuk National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Actiponin in people with Obesity, run by Chonbuk National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Fat Mass. (time frame: study visit 1(0 week), visit 2(4 week), visit 3(8 week) and visit 4(12 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.