Effect of Intake of Pyrus Pyrifolia Var. Culta(Makino) NaKai Peel Extract on Body Fat and Blood Lipid.
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 obesity
Started Mar 2016
Shorter than P25 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
April 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedApril 19, 2016
April 1, 2016
3 months
April 14, 2016
April 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in body fat mass
Body fat mass was measured in study baseline and visit 3(8 week)
8 week
Secondary Outcomes (6)
Changes in percent body fat
8 week
Change in fat free mass
8 week
Change in body mass index
8 week
Change in weight
8 week
Change in total cholesterol
8 week
- +1 more secondary outcomes
Study Arms (2)
Pyrus pyrifolia var. culta(Makino) NaKai peel extract
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University
Seoul, 133-791, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
April 14, 2016
First Posted
April 19, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
April 19, 2016
Record last verified: 2016-04