A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Zingiber Officinale Roscoe Extract on Body Fat
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Chonbuk National University Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes of body fat mass
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study was conducted to investigate the effects of daily supplementation of Zingiber officinale Roscoe extract on body fat.
Detailed Description
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty subjects were randomly divided into Zingiber officinale Roscoe extract 200 mg or placebo group. The investigators measured Body Fat Mass, Percent Body Fat, Fat Free Mass, weight, and body mass index.
Investigators
Soo-Wan Chae
Principal investigator, Clinical Trial Center for Functional Foods
Chonbuk National University Hospital
Eligibility Criteria
Inclusion Criteria
- •age between 19 and 65 years,
- •BMI 25\~29.9 kg/m2
- •subjects giving written informed consent
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 their absorption, such as gastrointestinal disease or gastrointestinal surgery
- •Participation in any other clinical trials 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 etc,.
Outcomes
Primary Outcomes
Changes of body fat mass
Time Frame: Baseline and 12 week
Body fat mass was measured in study baseline and 12 week
Secondary Outcomes
- Changes of percent body fat(Baseline and 12 week)
- Changes of fat free mass(Baseline and 12 week)
- Changes of weight(Baseline and 12 week)
- Changes of body mass index(Baseline and 12 week)