Obesity
Conditions
Brief summary
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Pyrus pyrifolia var. culta(Makino) NaKai peel extract on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
Interventions
DIETARY_SUPPLEMENTPyrus pyrifolia var. culta(Makino) NaKai peel extract
Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)
DIETARY_SUPPLEMENTPlacebo
Placebo(4g/day)
Sponsors
Hanyang University
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
* Males and females 19-65 years old * BMI(body mass index) 25\ 29.9 kg/m\^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women) * Able to give informed consent
Exclusion criteria
* BMI(body mass index) ≥ 30 kg/m\^2 * Significant variation in weight(more 10%) in the past 3 months * Allergic or hypersensitive to any of the ingredients in the test products * History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery * History of alcohol or substance abuse * 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 * Pregnant or lactating women etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body fat mass | 8 week | Body fat mass was measured in study baseline and visit 3(8 week) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in fat free mass | 8 week | Fat free mass was measured in study baseline and visit 3(8week) |
| Change in body mass index | 8 week | Body mass index was measured in study baseline and visit 3(8 week) |
| Changes in percent body fat | 8 week | Percent body fat was measured in study baseline and visit 3(8 week) |
| Change in total cholesterol | 8 week | Total cholesterol was measured in study baseline and visit 3(8 week) |
| Change in triglyceride | 8 week | Triglyceride was measured in study baseline and visit 3(8 week) |
| Change in weight | 8 week | Weight was measured in study baseline and visit 3(8 week) |
Countries
South Korea
Outcome results
None listed