Phase 2
N=80
Efficacy and Safety of Actiponin on Antiobesity in Obese Korean Subjects.
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01667224 ↗Enrolled (actual)
80
Serious AEs
—
Results posted
Apr 2014
Primary outcome: Primary: Changes in Body Fat Mass. — 22.65; 23.04; 22.28; 23.17 kg — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Actiponin (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Chonbuk National University Hospital
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Body Fat Mass. |
22.65; 23.04; 22.28; 23.17; 21.89; 23.15 | <0.05 sig |
| SECONDARY Changes in Abdominal Total Fat Area. |
332.24; 335.36; 311.35; 333.05 | <0.05 sig |
| SECONDARY Changes in Body Weight. |
76.56; 73.41; 76.26; 73.53; 75.57; 73.33 | <0.05 sig |
| SECONDARY Changes in Body Mss Index(BMI) |
27.8; 27.55; 27.69; 27.61; 27.44; 27.54 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01667224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.